Elizabeth Mechcatie

COLLEGE PARK, Md. – A Food and Drug Administration advisory panel on Nov. 18 split on whether to support approval of a noninvasive device intended to help physicians detect early melanomas.

At the meeting, the FDA’s General and Plastic Surgery Devices Panel voted 8 to 7 with 1 abstention that the data available supported approval of the MelaFind device to evaluate clinically atypical cutaneous pigmented lesions that have one or more characteristics of melanoma, "when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma." That is the indication proposed for approval by the manufacturer, Mela Sciences Inc.

The first device of this kind, MelaFind is a multispectral computer vision system with a handheld imager that captures the image of a lesion, and software that uses algorithms to analyze the image, indicating within 2 minutes whether a biopsy should be done, according to Mela Sciences. It is not intended to be used as a screening tool or in the evaluation of nonpigmented lesions or lesions considered definite melanomas.

The device was used by dermatologists in a pivotal study of 1,257 patients (mean age 47 years) on 1,632 pigmented skin lesions that had at least one characteristic of melanoma, which were also biopsied. Of the 114 lesions that were positive for melanoma on biopsy, 112 were tagged as positive by MelaFind, for a sensitivity of 98.3%, which the company compared to the sensitivity of 70%-80% for dermatologists that has been reported in the literature. (Sensitivity for the dermatologists could not be determined because the decision to perform a biopsy had already been made by the clinician before referring to MelaFind.) Specificity was 9.5%.

Panelists voting for and against approval were concerned about the use of this device in the hands of nondermatologists who might miss melanomas, but those voting in favor of approval said they believed with appropriate training, clinicians could learn to use the device effectively and that it would be a valuable tool. Concerns among those voting against approval included the need for more data, the risk of false negatives with the device, and issues with the data.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest prior to the meeting.

COLLEGE PARK, Md. – A Food and Drug Administration advisory panel on Nov. 18 split on whether to support approval of a noninvasive device intended to help physicians detect early melanomas.

At the meeting, the FDA’s General and Plastic Surgery Devices Panel voted 8 to 7 with 1 abstention that the data available supported approval of the MelaFind device to evaluate clinically atypical cutaneous pigmented lesions that have one or more characteristics of melanoma, "when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma." That is the indication proposed for approval by the manufacturer, Mela Sciences Inc.

The first device of this kind, MelaFind is a multispectral computer vision system with a handheld imager that captures the image of a lesion, and software that uses algorithms to analyze the image, indicating within 2 minutes whether a biopsy should be done, according to Mela Sciences. It is not intended to be used as a screening tool or in the evaluation of nonpigmented lesions or lesions considered definite melanomas.

The device was used by dermatologists in a pivotal study of 1,257 patients (mean age 47 years) on 1,632 pigmented skin lesions that had at least one characteristic of melanoma, which were also biopsied. Of the 114 lesions that were positive for melanoma on biopsy, 112 were tagged as positive by MelaFind, for a sensitivity of 98.3%, which the company compared to the sensitivity of 70%-80% for dermatologists that has been reported in the literature. (Sensitivity for the dermatologists could not be determined because the decision to perform a biopsy had already been made by the clinician before referring to MelaFind.) Specificity was 9.5%.

Panelists voting for and against approval were concerned about the use of this device in the hands of nondermatologists who might miss melanomas, but those voting in favor of approval said they believed with appropriate training, clinicians could learn to use the device effectively and that it would be a valuable tool. Concerns among those voting against approval included the need for more data, the risk of false negatives with the device, and issues with the data.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest prior to the meeting.

COLLEGE PARK, Md. – A Food and Drug Administration advisory panel on Nov. 18 split on whether to support approval of a noninvasive device intended to help physicians detect early melanomas.

At the meeting, the FDA’s General and Plastic Surgery Devices Panel voted 8 to 7 with 1 abstention that the data available supported approval of the MelaFind device to evaluate clinically atypical cutaneous pigmented lesions that have one or more characteristics of melanoma, "when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma." That is the indication proposed for approval by the manufacturer, Mela Sciences Inc.

The first device of this kind, MelaFind is a multispectral computer vision system with a handheld imager that captures the image of a lesion, and software that uses algorithms to analyze the image, indicating within 2 minutes whether a biopsy should be done, according to Mela Sciences. It is not intended to be used as a screening tool or in the evaluation of nonpigmented lesions or lesions considered definite melanomas.

The device was used by dermatologists in a pivotal study of 1,257 patients (mean age 47 years) on 1,632 pigmented skin lesions that had at least one characteristic of melanoma, which were also biopsied. Of the 114 lesions that were positive for melanoma on biopsy, 112 were tagged as positive by MelaFind, for a sensitivity of 98.3%, which the company compared to the sensitivity of 70%-80% for dermatologists that has been reported in the literature. (Sensitivity for the dermatologists could not be determined because the decision to perform a biopsy had already been made by the clinician before referring to MelaFind.) Specificity was 9.5%.

Panelists voting for and against approval were concerned about the use of this device in the hands of nondermatologists who might miss melanomas, but those voting in favor of approval said they believed with appropriate training, clinicians could learn to use the device effectively and that it would be a valuable tool. Concerns among those voting against approval included the need for more data, the risk of false negatives with the device, and issues with the data.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest prior to the meeting.

The injectable extended-release formulation of naltrexone, marketed as Vivitrol, has been approved as a treatment for preventing relapses in people who have undergone opioid detoxification, the Food and Drug Administration announced.

Vivitrol, which was approved in 2006 for the treatment of alcohol dependence, is administered in an intramuscular injection once a month, in patients who have no opioids remaining in their system.

If opioids are present, patients may experience withdrawal symptoms, according to the FDA statement. Naltrexone is an opioid antagonist.

Approval was based on the results of a 6-month study of 250 patients who were completing or had recently completed detoxification and were no longer physically dependent on opioids.

Between the 5th week and the end of the study, 36% of those treated with Vivitrol (one 380-mg injection once a month) had not used opioids at all, compared with 23% of those on placebo, a significant difference. All patients received psychosocial support during the study.

Side effects associated with Vivitrol treatment include nausea, fatigue, headache, dizziness, vomiting, reduced appetite, painful joints, and muscle cramps, the FDA statement said.

Serious side effects include injection site reactions, allergic reactions, hepatotoxicity, and depression, as well as suicide and suicidal thoughts and behavior.

Customized needles provided in the Vivitrol package must be used to inject the medication as an intramuscular gluteal injection, according to the FDA and Alkermes Inc., the manufacturer of Vivitrol.

The FDA has asked the company to conduct postmarketing pharmacokinetic and efficacy studies of Vivitrol in patients aged 12-16 years.

Serious adverse reactions associated with Vivitrol should be reported to the FDA's MedWatch program at 800-332-1088 or www.fda.gov/medwatch

The injectable extended-release formulation of naltrexone, marketed as Vivitrol, has been approved as a treatment for preventing relapses in people who have undergone opioid detoxification, the Food and Drug Administration announced.

Vivitrol, which was approved in 2006 for the treatment of alcohol dependence, is administered in an intramuscular injection once a month, in patients who have no opioids remaining in their system.

If opioids are present, patients may experience withdrawal symptoms, according to the FDA statement. Naltrexone is an opioid antagonist.

Approval was based on the results of a 6-month study of 250 patients who were completing or had recently completed detoxification and were no longer physically dependent on opioids.

Between the 5th week and the end of the study, 36% of those treated with Vivitrol (one 380-mg injection once a month) had not used opioids at all, compared with 23% of those on placebo, a significant difference. All patients received psychosocial support during the study.

Side effects associated with Vivitrol treatment include nausea, fatigue, headache, dizziness, vomiting, reduced appetite, painful joints, and muscle cramps, the FDA statement said.

Serious side effects include injection site reactions, allergic reactions, hepatotoxicity, and depression, as well as suicide and suicidal thoughts and behavior.

Customized needles provided in the Vivitrol package must be used to inject the medication as an intramuscular gluteal injection, according to the FDA and Alkermes Inc., the manufacturer of Vivitrol.

The FDA has asked the company to conduct postmarketing pharmacokinetic and efficacy studies of Vivitrol in patients aged 12-16 years.

Serious adverse reactions associated with Vivitrol should be reported to the FDA's MedWatch program at 800-332-1088 or www.fda.gov/medwatch

The injectable extended-release formulation of naltrexone, marketed as Vivitrol, has been approved as a treatment for preventing relapses in people who have undergone opioid detoxification, the Food and Drug Administration announced.

Vivitrol, which was approved in 2006 for the treatment of alcohol dependence, is administered in an intramuscular injection once a month, in patients who have no opioids remaining in their system.

If opioids are present, patients may experience withdrawal symptoms, according to the FDA statement. Naltrexone is an opioid antagonist.

Approval was based on the results of a 6-month study of 250 patients who were completing or had recently completed detoxification and were no longer physically dependent on opioids.

Between the 5th week and the end of the study, 36% of those treated with Vivitrol (one 380-mg injection once a month) had not used opioids at all, compared with 23% of those on placebo, a significant difference. All patients received psychosocial support during the study.

Side effects associated with Vivitrol treatment include nausea, fatigue, headache, dizziness, vomiting, reduced appetite, painful joints, and muscle cramps, the FDA statement said.

Serious side effects include injection site reactions, allergic reactions, hepatotoxicity, and depression, as well as suicide and suicidal thoughts and behavior.

Customized needles provided in the Vivitrol package must be used to inject the medication as an intramuscular gluteal injection, according to the FDA and Alkermes Inc., the manufacturer of Vivitrol.

The FDA has asked the company to conduct postmarketing pharmacokinetic and efficacy studies of Vivitrol in patients aged 12-16 years.

Serious adverse reactions associated with Vivitrol should be reported to the FDA's MedWatch program at 800-332-1088 or www.fda.gov/medwatch

Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone-releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone-releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone-releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone–releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone–releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone–releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone–releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone–releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

Tesamorelin, a growth hormone releasing factor drug, has been approved by the Food and Drug Administration to treat people with HIV who have lipodystrophy, a side effect of long-term antiretroviral drug therapy.

This is the first treatment approved for this indication, according to an FDA statement announcing the Nov. 10 approval.

Tesamorelin, which is administered in a subcutaneous injection once daily, was approved to "induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy," according to the FDA. Tesamorelin will be marketed as Egrifta by EMD Serono Inc. It was developed by Canadian-based Theratechnologies Inc.

At a meeting in May, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously agreed that tesamorelin had a favorable risk-benefit profile that supported approval in this population.

Lipodystrophy is characterized by the accumulation of excess fat in different parts of the body, mostly around the liver, stomach, and other abdominal organs.

Approval was based on two placebo-controlled studies of HIV-positive adults with lipodystrophy, who were on stable antiretroviral therapy. The studies showed that over a 26-week period, 534 patients who were treated with tesamorelin had greater reductions in abdominal fat as measured by CT scans, compared with 261 patients who received placebo injections. Some patients also reported improvements in self-image. "Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied," the FDA statement noted.

Arthralgia, injection site reactions, stomach pain, and myalgia were among the most common side effects associated with treatment. Small increases in fasting blood sugar and increases in HbA1c levels were also reported among patients treated with tesamorelin, including cases that met the criteria for a diabetes diagnosis, according to data presented at the meeting.

Tesamorelin activates the growth hormone–releasing hormone receptor in the pituitary, stimulating the production of growth hormone.

GAITHERSBURG, Md. - Intravenous phenytoin should continue to be marketed but with revisions to its label that include more information about the risk of "purple glove syndrome" associated with its use, advisors to the Food and Drug Administration recommended on Nov. 3.

At a joint meeting of the FDA's Peripheral and Central Nervous System Drugs and the Drug Safety and Risk Management Advisory committees, panelists reviewed the available evidence on the risk of purple glove syndrome (PGS) associated with the use of IV phenytoin, which was approved in 1956.

IV phenytoin has been associated with PGS, a local reaction that can start within hours of the infusion with edema and purple discoloration around the infusion site. This edema and discoloration can progress but usually resolves within days to weeks. However, in some cases, it leads to necrosis of the skin, ischemia, and in rare cases, amputation.

Since a pro-drug of phenytoin – IV fosphenytoin – was approved in 1996 and is now being used more often than IV phenytoin, the risk of PGS associated with the drug has become a larger issue. The current uses of the two drugs include the treatment of status epilepticus and the prevention and treatment of seizures during neurosurgery.

Most of the panel members agreed that IV phenytoin treatment was associated with PGS. Several panelists said that although the incidence of PGS associated with IV phenytoin was not clear, it is probably uncommon. The panel members voted 18 to 11 that there was not enough evidence to conclude that IV fosphenytoin causes PGS. However, most of those voting no said that a link was possible and that the incidence was likely much less common and less severe than with IV phenytoin.

The panel members unanimously agreed that more regulatory action regarding IV fosphenytoin was needed, including additional dosing information, because its current label is confusing and has resulted in medication errors.

An issue that was raised by some panel members was the current shortage of IV fosphenytoin, despite the availability of generic formulations. Pfizer Inc., which markets the brand version of the drug as Cerebyx, stopped marketing it in the United States because of problems finding a U.S. manufacturer. The company continues to market Cerebyx outside of the United States, according to Pfizer representatives at the meeting.

FDA reviewers identified 11 reports of PGS in the literature in patients aged 6 months to 86 years that were associated with IV phenytoin. PGS resolved in most cases except for one that ended in amputation of the affected extremity. The incidence of PGS associated with IV phenytoin treatment in the literature ranges from 0% to 6%, mostly resulting in outcomes that are not considered serious, according to the FDA.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of conflicts of interest related to the topic of the meeting.

GAITHERSBURG, Md. - Intravenous phenytoin should continue to be marketed but with revisions to its label that include more information about the risk of "purple glove syndrome" associated with its use, advisors to the Food and Drug Administration recommended on Nov. 3.

At a joint meeting of the FDA's Peripheral and Central Nervous System Drugs and the Drug Safety and Risk Management Advisory committees, panelists reviewed the available evidence on the risk of purple glove syndrome (PGS) associated with the use of IV phenytoin, which was approved in 1956.

IV phenytoin has been associated with PGS, a local reaction that can start within hours of the infusion with edema and purple discoloration around the infusion site. This edema and discoloration can progress but usually resolves within days to weeks. However, in some cases, it leads to necrosis of the skin, ischemia, and in rare cases, amputation.

Since a pro-drug of phenytoin – IV fosphenytoin – was approved in 1996 and is now being used more often than IV phenytoin, the risk of PGS associated with the drug has become a larger issue. The current uses of the two drugs include the treatment of status epilepticus and the prevention and treatment of seizures during neurosurgery.

Most of the panel members agreed that IV phenytoin treatment was associated with PGS. Several panelists said that although the incidence of PGS associated with IV phenytoin was not clear, it is probably uncommon. The panel members voted 18 to 11 that there was not enough evidence to conclude that IV fosphenytoin causes PGS. However, most of those voting no said that a link was possible and that the incidence was likely much less common and less severe than with IV phenytoin.

The panel members unanimously agreed that more regulatory action regarding IV fosphenytoin was needed, including additional dosing information, because its current label is confusing and has resulted in medication errors.

An issue that was raised by some panel members was the current shortage of IV fosphenytoin, despite the availability of generic formulations. Pfizer Inc., which markets the brand version of the drug as Cerebyx, stopped marketing it in the United States because of problems finding a U.S. manufacturer. The company continues to market Cerebyx outside of the United States, according to Pfizer representatives at the meeting.

FDA reviewers identified 11 reports of PGS in the literature in patients aged 6 months to 86 years that were associated with IV phenytoin. PGS resolved in most cases except for one that ended in amputation of the affected extremity. The incidence of PGS associated with IV phenytoin treatment in the literature ranges from 0% to 6%, mostly resulting in outcomes that are not considered serious, according to the FDA.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of conflicts of interest related to the topic of the meeting.

GAITHERSBURG, Md. - Intravenous phenytoin should continue to be marketed but with revisions to its label that include more information about the risk of "purple glove syndrome" associated with its use, advisors to the Food and Drug Administration recommended on Nov. 3.

At a joint meeting of the FDA's Peripheral and Central Nervous System Drugs and the Drug Safety and Risk Management Advisory committees, panelists reviewed the available evidence on the risk of purple glove syndrome (PGS) associated with the use of IV phenytoin, which was approved in 1956.

IV phenytoin has been associated with PGS, a local reaction that can start within hours of the infusion with edema and purple discoloration around the infusion site. This edema and discoloration can progress but usually resolves within days to weeks. However, in some cases, it leads to necrosis of the skin, ischemia, and in rare cases, amputation.

Since a pro-drug of phenytoin – IV fosphenytoin – was approved in 1996 and is now being used more often than IV phenytoin, the risk of PGS associated with the drug has become a larger issue. The current uses of the two drugs include the treatment of status epilepticus and the prevention and treatment of seizures during neurosurgery.

Most of the panel members agreed that IV phenytoin treatment was associated with PGS. Several panelists said that although the incidence of PGS associated with IV phenytoin was not clear, it is probably uncommon. The panel members voted 18 to 11 that there was not enough evidence to conclude that IV fosphenytoin causes PGS. However, most of those voting no said that a link was possible and that the incidence was likely much less common and less severe than with IV phenytoin.

The panel members unanimously agreed that more regulatory action regarding IV fosphenytoin was needed, including additional dosing information, because its current label is confusing and has resulted in medication errors.

An issue that was raised by some panel members was the current shortage of IV fosphenytoin, despite the availability of generic formulations. Pfizer Inc., which markets the brand version of the drug as Cerebyx, stopped marketing it in the United States because of problems finding a U.S. manufacturer. The company continues to market Cerebyx outside of the United States, according to Pfizer representatives at the meeting.

FDA reviewers identified 11 reports of PGS in the literature in patients aged 6 months to 86 years that were associated with IV phenytoin. PGS resolved in most cases except for one that ended in amputation of the affected extremity. The incidence of PGS associated with IV phenytoin treatment in the literature ranges from 0% to 6%, mostly resulting in outcomes that are not considered serious, according to the FDA.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of conflicts of interest related to the topic of the meeting.

Everolimus, a kinase inhibitor already approved for treating kidney cancer, has been approved as a treatment for slowly growing, benign tumors in patients with tuberous sclerosis, the Food and Drug Administration announced on Nov. 1.

Everolimus, marketed as Afinitor for kidney cancer, was approved for treating subependymal giant cell astrocytoma (SEGA) associated with the rare genetic disorder, in cases in which these tumors cannot be treated surgically. (Everolimus is also approved for prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant and is marketed as Zortress for this indication.) It will be marketed as Afinitor for the SEGA indication and will be available in a tablet formulation.

"Patients with this disease currently have limited treatment options beyond surgical intervention," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research, said in an FDA statement announcing the approval. "It is important for research to continue in rare diseases where patients have few or no existing drug treatment options." About 6%-9% of patients with tuberous sclerosis have SEGAs, which are potentially fatal, slow-growing tumors.

The accelerated approval was based on a study of 28 patients with SEGAs, which found that after 6 months of treatment, 9 patients (32%) had more than a 50% reduction in the volume of their largest SEGA tumor, which included several patients whose tumors had recurred after surgery. The duration of response in these patients ranged from about 3 months to 2½ years (median 266 days). Of the nine patients, seven still had a 50% reduction in tumor volume at the last follow-up, according to the FDA.

In addition, none of the patients in the study developed any new tumors, although none of the tumors completely resolved.

The most common adverse events reported by patients in patients treated for SEGA included upper respiratory tract infections, sinus and ear infections, mouth sores, and fever. Laboratory test abnormalities associated with treatment included liver enzyme elevations, hyperlipidemia, high blood sugar, and decreases in white blood cells, red blood cells, and platelets.

Everolimus was approved in 2009 for the kidney cancer indication, in patients who failed treatment with sunitinib (Sutent) or sorafenib (Nexavar).

Everolimus, a kinase inhibitor already approved for treating kidney cancer, has been approved as a treatment for slowly growing, benign tumors in patients with tuberous sclerosis, the Food and Drug Administration announced on Nov. 1.

Everolimus, marketed as Afinitor for kidney cancer, was approved for treating subependymal giant cell astrocytoma (SEGA) associated with the rare genetic disorder, in cases in which these tumors cannot be treated surgically. (Everolimus is also approved for prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant and is marketed as Zortress for this indication.) It will be marketed as Afinitor for the SEGA indication and will be available in a tablet formulation.

"Patients with this disease currently have limited treatment options beyond surgical intervention," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research, said in an FDA statement announcing the approval. "It is important for research to continue in rare diseases where patients have few or no existing drug treatment options." About 6%-9% of patients with tuberous sclerosis have SEGAs, which are potentially fatal, slow-growing tumors.

The accelerated approval was based on a study of 28 patients with SEGAs, which found that after 6 months of treatment, 9 patients (32%) had more than a 50% reduction in the volume of their largest SEGA tumor, which included several patients whose tumors had recurred after surgery. The duration of response in these patients ranged from about 3 months to 2½ years (median 266 days). Of the nine patients, seven still had a 50% reduction in tumor volume at the last follow-up, according to the FDA.

In addition, none of the patients in the study developed any new tumors, although none of the tumors completely resolved.

The most common adverse events reported by patients in patients treated for SEGA included upper respiratory tract infections, sinus and ear infections, mouth sores, and fever. Laboratory test abnormalities associated with treatment included liver enzyme elevations, hyperlipidemia, high blood sugar, and decreases in white blood cells, red blood cells, and platelets.

Everolimus was approved in 2009 for the kidney cancer indication, in patients who failed treatment with sunitinib (Sutent) or sorafenib (Nexavar).

Everolimus, a kinase inhibitor already approved for treating kidney cancer, has been approved as a treatment for slowly growing, benign tumors in patients with tuberous sclerosis, the Food and Drug Administration announced on Nov. 1.

Everolimus, marketed as Afinitor for kidney cancer, was approved for treating subependymal giant cell astrocytoma (SEGA) associated with the rare genetic disorder, in cases in which these tumors cannot be treated surgically. (Everolimus is also approved for prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant and is marketed as Zortress for this indication.) It will be marketed as Afinitor for the SEGA indication and will be available in a tablet formulation.

"Patients with this disease currently have limited treatment options beyond surgical intervention," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research, said in an FDA statement announcing the approval. "It is important for research to continue in rare diseases where patients have few or no existing drug treatment options." About 6%-9% of patients with tuberous sclerosis have SEGAs, which are potentially fatal, slow-growing tumors.

The accelerated approval was based on a study of 28 patients with SEGAs, which found that after 6 months of treatment, 9 patients (32%) had more than a 50% reduction in the volume of their largest SEGA tumor, which included several patients whose tumors had recurred after surgery. The duration of response in these patients ranged from about 3 months to 2½ years (median 266 days). Of the nine patients, seven still had a 50% reduction in tumor volume at the last follow-up, according to the FDA.

In addition, none of the patients in the study developed any new tumors, although none of the tumors completely resolved.

The most common adverse events reported by patients in patients treated for SEGA included upper respiratory tract infections, sinus and ear infections, mouth sores, and fever. Laboratory test abnormalities associated with treatment included liver enzyme elevations, hyperlipidemia, high blood sugar, and decreases in white blood cells, red blood cells, and platelets.

Everolimus was approved in 2009 for the kidney cancer indication, in patients who failed treatment with sunitinib (Sutent) or sorafenib (Nexavar).

Everolimus, a kinase inhibitor already approved for treating kidney cancer, has been approved as a treatment for slowly growing, benign tumors in patients with tuberous sclerosis, the Food and Drug Administration announced on Nov. 1.

Everolimus, marketed as Afinitor for kidney cancer, was approved for treating subependymal giant cell astrocytoma (SEGA) associated with the rare genetic disorder, in cases in which these tumors cannot be treated surgically. (Everolimus is also approved for prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant and is marketed as Zortress for this indication.) It will be marketed as Afinitor for the SEGA indication and will be available in a tablet formulation.

"Patients with this disease currently have limited treatment options beyond surgical intervention," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research, said in an FDA statement announcing the approval. "It is important for research to continue in rare diseases where patients have few or no existing drug treatment options." About 6%-9% of patients with tuberous sclerosis have SEGAs, which are potentially fatal, slow-growing tumors.

The accelerated approval was based on a study of 28 patients with SEGAs, which found that after 6 months of treatment, 9 patients (32%) had more than a 50% reduction in the volume of their largest SEGA tumor, which included several patients whose tumors had recurred after surgery. The duration of response in these patients ranged from about 3 months to 2½ years (median 266 days). Of the nine patients, seven still had a 50% reduction in tumor volume at the last follow-up, according to the FDA.

In addition, none of the patients in the study developed any new tumors, although none of the tumors completely resolved.

The most common adverse events reported by patients in patients treated for SEGA included upper respiratory tract infections, sinus and ear infections, mouth sores, and fever. Laboratory test abnormalities associated with treatment included liver enzyme elevations, hyperlipidemia, high blood sugar, and decreases in white blood cells, red blood cells, and platelets.

Everolimus was approved in 2009 for the kidney cancer indication, in patients who failed treatment with sunitinib (Sutent) or sorafenib (Nexavar).

Everolimus, a kinase inhibitor already approved for treating kidney cancer, has been approved as a treatment for slowly growing, benign tumors in patients with tuberous sclerosis, the Food and Drug Administration announced on Nov. 1.

Everolimus, marketed as Afinitor for kidney cancer, was approved for treating subependymal giant cell astrocytoma (SEGA) associated with the rare genetic disorder, in cases in which these tumors cannot be treated surgically. (Everolimus is also approved for prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant and is marketed as Zortress for this indication.) It will be marketed as Afinitor for the SEGA indication and will be available in a tablet formulation.

"Patients with this disease currently have limited treatment options beyond surgical intervention," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research, said in an FDA statement announcing the approval. "It is important for research to continue in rare diseases where patients have few or no existing drug treatment options." About 6%-9% of patients with tuberous sclerosis have SEGAs, which are potentially fatal, slow-growing tumors.

The accelerated approval was based on a study of 28 patients with SEGAs, which found that after 6 months of treatment, 9 patients (32%) had more than a 50% reduction in the volume of their largest SEGA tumor, which included several patients whose tumors had recurred after surgery. The duration of response in these patients ranged from about 3 months to 2½ years (median 266 days). Of the nine patients, seven still had a 50% reduction in tumor volume at the last follow-up, according to the FDA.

In addition, none of the patients in the study developed any new tumors, although none of the tumors completely resolved.

The most common adverse events reported by patients in patients treated for SEGA included upper respiratory tract infections, sinus and ear infections, mouth sores, and fever. Laboratory test abnormalities associated with treatment included liver enzyme elevations, hyperlipidemia, high blood sugar, and decreases in white blood cells, red blood cells, and platelets.

Everolimus was approved in 2009 for the kidney cancer indication, in patients who failed treatment with sunitinib (Sutent) or sorafenib (Nexavar).

Everolimus, a kinase inhibitor already approved for treating kidney cancer, has been approved as a treatment for slowly growing, benign tumors in patients with tuberous sclerosis, the Food and Drug Administration announced on Nov. 1.

Everolimus, marketed as Afinitor for kidney cancer, was approved for treating subependymal giant cell astrocytoma (SEGA) associated with the rare genetic disorder, in cases in which these tumors cannot be treated surgically. (Everolimus is also approved for prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant and is marketed as Zortress for this indication.) It will be marketed as Afinitor for the SEGA indication and will be available in a tablet formulation.

"Patients with this disease currently have limited treatment options beyond surgical intervention," Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research, said in an FDA statement announcing the approval. "It is important for research to continue in rare diseases where patients have few or no existing drug treatment options." About 6%-9% of patients with tuberous sclerosis have SEGAs, which are potentially fatal, slow-growing tumors.

The accelerated approval was based on a study of 28 patients with SEGAs, which found that after 6 months of treatment, 9 patients (32%) had more than a 50% reduction in the volume of their largest SEGA tumor, which included several patients whose tumors had recurred after surgery. The duration of response in these patients ranged from about 3 months to 2½ years (median 266 days). Of the nine patients, seven still had a 50% reduction in tumor volume at the last follow-up, according to the FDA.

In addition, none of the patients in the study developed any new tumors, although none of the tumors completely resolved.

The most common adverse events reported by patients in patients treated for SEGA included upper respiratory tract infections, sinus and ear infections, mouth sores, and fever. Laboratory test abnormalities associated with treatment included liver enzyme elevations, hyperlipidemia, high blood sugar, and decreases in white blood cells, red blood cells, and platelets.

Everolimus was approved in 2009 for the kidney cancer indication, in patients who failed treatment with sunitinib (Sutent) or sorafenib (Nexavar).

Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:

– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.

In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).

Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.

At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.

Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:

– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.

In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).

Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.

At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.

Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:

– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.

In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).

Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.

At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.

Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:

– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.

In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).

Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.

At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.

Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:

– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.

In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).

Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.

At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.

Ceftaroline, an intravenous cephalosporin antibiotic, has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:

– the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

– the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval.

In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam).

Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA.

At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.