FDA approves first generics of pregabalin

FDA announced Monday that it has approved nine applications for the generic versions of pregabalin (Lyrica—Pfizer) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients aged 17 years a

FDA announced Monday that it has approved nine applications for the generic versions of pregabalin (Lyrica—Pfizer) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients aged 17 years and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury. "Today's approval of the first generics for pregabalin, a widely used medication, is another example of the FDA's longstanding commitment to advance patient access to lower cost, high-quality generic medicines," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research. "Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA," she added. According to FDA, pregabalin must be dispensed with a patient medication guide that include key information about its uses and risks, including the risk of angioedema, which may be associated with life-threatening respiratory compromise requiring emergency treatment. Additionally, hypersensitivity reactions such as hives and wheezing may occur, and increased seizure frequency and other adverse reactions may occur if the drug is rapidly discontinued. FDA noted, "Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Additionally, pregabalin may cause peripheral edema (swelling of hands or legs) so caution should be exercised when co-administering it with thiazolidinedione antidiabetic agents. Pregabalin may cause dizziness and drowsiness and impair ability to drive or operate machinery." The most frequent adverse effects reported in clinical trials for pregabalin are dizziness, somnoloence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking. FDA granted approvals for the generic versions of pregabalin to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals.