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Pacira Pharmaceuticals’ Exparel (bupivacaine liposome injectable suspension), used for pain management following surgery, is not limited to any specific surgery type, following the rescission of a warning letter issued by the Food and Drug Administration.
In a Dec. 14 letter to Exparel manufacturer Pacira Pharmaceuticals, the FDA said it was rescinding a September 2014 warning letter, noting that after reviewing the warning letter, the agency “determined that different statements in various parts of the approved labeling created ambiguity with respect to the scope of the approved indication.”
In doing so, the FDA clarified that Exparel is not limited to bunionectomy and hemorrhoidectomy procedures, which were what the drug was tested on in its pivotal trials.
The letter also offers guidance to say that Exparel is indicated for transversus abdominis plane blocks, and the indication does encompass use for postoperative analgesia when administered as local infiltration at the site of oral surgical procedures, including tooth extractions.
Pacira Pharmaceuticals’ Exparel (bupivacaine liposome injectable suspension), used for pain management following surgery, is not limited to any specific surgery type, following the rescission of a warning letter issued by the Food and Drug Administration.
In a Dec. 14 letter to Exparel manufacturer Pacira Pharmaceuticals, the FDA said it was rescinding a September 2014 warning letter, noting that after reviewing the warning letter, the agency “determined that different statements in various parts of the approved labeling created ambiguity with respect to the scope of the approved indication.”
In doing so, the FDA clarified that Exparel is not limited to bunionectomy and hemorrhoidectomy procedures, which were what the drug was tested on in its pivotal trials.
The letter also offers guidance to say that Exparel is indicated for transversus abdominis plane blocks, and the indication does encompass use for postoperative analgesia when administered as local infiltration at the site of oral surgical procedures, including tooth extractions.
Pacira Pharmaceuticals’ Exparel (bupivacaine liposome injectable suspension), used for pain management following surgery, is not limited to any specific surgery type, following the rescission of a warning letter issued by the Food and Drug Administration.
In a Dec. 14 letter to Exparel manufacturer Pacira Pharmaceuticals, the FDA said it was rescinding a September 2014 warning letter, noting that after reviewing the warning letter, the agency “determined that different statements in various parts of the approved labeling created ambiguity with respect to the scope of the approved indication.”
In doing so, the FDA clarified that Exparel is not limited to bunionectomy and hemorrhoidectomy procedures, which were what the drug was tested on in its pivotal trials.
The letter also offers guidance to say that Exparel is indicated for transversus abdominis plane blocks, and the indication does encompass use for postoperative analgesia when administered as local infiltration at the site of oral surgical procedures, including tooth extractions.
