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Cosentyx
Novartis Pharmaceuticals Corporation announces US Food and Drug Administration approval of 2 new indications for Cosentyx (secukinumab): to treat patients with active ankylosing spondylitis and active psoriatic arthritis. Cosentyx is a human monoclonal antibody that selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor. Research suggests that IL-17A may play an important role in driving the body’s immune response in psoriasis, psoriatic arthritis, and ankylosing spondylitis. Cosentyx was approved in January 2015 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. For more information, visit www.cosentyx.com.
Emverm
Impax Laboratories, Inc, receives US Food and Drug Administration approval for the supplemental new drug application of Emverm (mebendazole) 100-mg chewable tablets for the treatment of pinworm and certain worm infections. Emverm is indicated for treatment of pinworm, whipworm, common roundworm, common hookworm, and American hookworm in single or mixed infections. Emverm is expected to become available early in the second quarter of 2016. For more information, visit www.impaxlabs.com.
Keytruda
Merck & Co, Inc, announces US Food and Drug Administration approval of an expanded indication for Keytruda (pembrolizumab) that includes the first-line treatment of patients with unresectable or metastatic melanoma. Keytruda is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Keytruda is an anti–programmed death receptor-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. For more information, visit www.keytruda.com.
Opdivo + Yervoy Regimen
The US Food and Drug Administration has granted accelerated approval of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. An international, multicenter, double-blind, randomized, active-controlled trial in patients who were previously untreated for unresectable or metastatic BRAF V600 wild-type melanoma demonstrated an increase in the objective response rate, prolonged response durations, and improvement in progression-free survival. When used in combination with ipilimumab, the recommended dose and schedule is nivolumab 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day every 3 weeks for 4 doses. The recommended subsequent dose of nivolumab, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. For more information, visit www.opdivoyervoyhcp.com.
TriAcnéal Day Mattifying Lotion and Night Smoothing Lotion
Pierre Fabre Dermo-Cosmetique USA introduces 2 TriAcnéal lotions in the Avène line for the treatment and prevention of acne. TriAcnéal Day Mattifying Lotion provides hydrating and mattifying care. It is gentle enough for daily use and can be used alone or in combination with topical acne prescriptions. A trio of ingredients target acne: PCC enzyme (consisting of papain, sodium alginate, caprylyl glycol, and hexanediol) for exfoliation to counteract the formation of new comedones, Diolényl (consisting of caprylyl glycol linseedate and potassium sorbate)to treat existing blemishes and prevent new lesions, and glyceryl laurate to reduce oil production. TriAcnéal Night Smoothing Lotion works to reduce the appearance of acne scars and provides moisturization and redness-reduction benefits. The nighttime formula contains PCC enzyme and Diolényl as well as retinaldehyde to diminish visible signs of aging. For more information, visit www.aveneusa.com.
If you would like your product included in Product News, please e-mail a press release to the Editorial Office at cutis@frontlinemedcom.com.
Cosentyx
Novartis Pharmaceuticals Corporation announces US Food and Drug Administration approval of 2 new indications for Cosentyx (secukinumab): to treat patients with active ankylosing spondylitis and active psoriatic arthritis. Cosentyx is a human monoclonal antibody that selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor. Research suggests that IL-17A may play an important role in driving the body’s immune response in psoriasis, psoriatic arthritis, and ankylosing spondylitis. Cosentyx was approved in January 2015 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. For more information, visit www.cosentyx.com.
Emverm
Impax Laboratories, Inc, receives US Food and Drug Administration approval for the supplemental new drug application of Emverm (mebendazole) 100-mg chewable tablets for the treatment of pinworm and certain worm infections. Emverm is indicated for treatment of pinworm, whipworm, common roundworm, common hookworm, and American hookworm in single or mixed infections. Emverm is expected to become available early in the second quarter of 2016. For more information, visit www.impaxlabs.com.
Keytruda
Merck & Co, Inc, announces US Food and Drug Administration approval of an expanded indication for Keytruda (pembrolizumab) that includes the first-line treatment of patients with unresectable or metastatic melanoma. Keytruda is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Keytruda is an anti–programmed death receptor-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. For more information, visit www.keytruda.com.
Opdivo + Yervoy Regimen
The US Food and Drug Administration has granted accelerated approval of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. An international, multicenter, double-blind, randomized, active-controlled trial in patients who were previously untreated for unresectable or metastatic BRAF V600 wild-type melanoma demonstrated an increase in the objective response rate, prolonged response durations, and improvement in progression-free survival. When used in combination with ipilimumab, the recommended dose and schedule is nivolumab 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day every 3 weeks for 4 doses. The recommended subsequent dose of nivolumab, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. For more information, visit www.opdivoyervoyhcp.com.
TriAcnéal Day Mattifying Lotion and Night Smoothing Lotion
Pierre Fabre Dermo-Cosmetique USA introduces 2 TriAcnéal lotions in the Avène line for the treatment and prevention of acne. TriAcnéal Day Mattifying Lotion provides hydrating and mattifying care. It is gentle enough for daily use and can be used alone or in combination with topical acne prescriptions. A trio of ingredients target acne: PCC enzyme (consisting of papain, sodium alginate, caprylyl glycol, and hexanediol) for exfoliation to counteract the formation of new comedones, Diolényl (consisting of caprylyl glycol linseedate and potassium sorbate)to treat existing blemishes and prevent new lesions, and glyceryl laurate to reduce oil production. TriAcnéal Night Smoothing Lotion works to reduce the appearance of acne scars and provides moisturization and redness-reduction benefits. The nighttime formula contains PCC enzyme and Diolényl as well as retinaldehyde to diminish visible signs of aging. For more information, visit www.aveneusa.com.
If you would like your product included in Product News, please e-mail a press release to the Editorial Office at cutis@frontlinemedcom.com.
Cosentyx
Novartis Pharmaceuticals Corporation announces US Food and Drug Administration approval of 2 new indications for Cosentyx (secukinumab): to treat patients with active ankylosing spondylitis and active psoriatic arthritis. Cosentyx is a human monoclonal antibody that selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor. Research suggests that IL-17A may play an important role in driving the body’s immune response in psoriasis, psoriatic arthritis, and ankylosing spondylitis. Cosentyx was approved in January 2015 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. For more information, visit www.cosentyx.com.
Emverm
Impax Laboratories, Inc, receives US Food and Drug Administration approval for the supplemental new drug application of Emverm (mebendazole) 100-mg chewable tablets for the treatment of pinworm and certain worm infections. Emverm is indicated for treatment of pinworm, whipworm, common roundworm, common hookworm, and American hookworm in single or mixed infections. Emverm is expected to become available early in the second quarter of 2016. For more information, visit www.impaxlabs.com.
Keytruda
Merck & Co, Inc, announces US Food and Drug Administration approval of an expanded indication for Keytruda (pembrolizumab) that includes the first-line treatment of patients with unresectable or metastatic melanoma. Keytruda is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Keytruda is an anti–programmed death receptor-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. For more information, visit www.keytruda.com.
Opdivo + Yervoy Regimen
The US Food and Drug Administration has granted accelerated approval of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. An international, multicenter, double-blind, randomized, active-controlled trial in patients who were previously untreated for unresectable or metastatic BRAF V600 wild-type melanoma demonstrated an increase in the objective response rate, prolonged response durations, and improvement in progression-free survival. When used in combination with ipilimumab, the recommended dose and schedule is nivolumab 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day every 3 weeks for 4 doses. The recommended subsequent dose of nivolumab, as a single agent, is 3 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. For more information, visit www.opdivoyervoyhcp.com.
TriAcnéal Day Mattifying Lotion and Night Smoothing Lotion
Pierre Fabre Dermo-Cosmetique USA introduces 2 TriAcnéal lotions in the Avène line for the treatment and prevention of acne. TriAcnéal Day Mattifying Lotion provides hydrating and mattifying care. It is gentle enough for daily use and can be used alone or in combination with topical acne prescriptions. A trio of ingredients target acne: PCC enzyme (consisting of papain, sodium alginate, caprylyl glycol, and hexanediol) for exfoliation to counteract the formation of new comedones, Diolényl (consisting of caprylyl glycol linseedate and potassium sorbate)to treat existing blemishes and prevent new lesions, and glyceryl laurate to reduce oil production. TriAcnéal Night Smoothing Lotion works to reduce the appearance of acne scars and provides moisturization and redness-reduction benefits. The nighttime formula contains PCC enzyme and Diolényl as well as retinaldehyde to diminish visible signs of aging. For more information, visit www.aveneusa.com.
If you would like your product included in Product News, please e-mail a press release to the Editorial Office at cutis@frontlinemedcom.com.
