FDA approves first generics of pregabalin

The Food and Drug Administration has approved the first generics of pregabalin (Lyrica) for the treatment of a variety of diseases.

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The generics were approved to manage neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia, as well as neuropathic pain associated with spinal cord injury, and as an adjunctive therapy for the treatment of partial-onset seizures in patients aged 17 years and older. Approvals were granted to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

The most common adverse events associated with pregabalin include dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking. Pregabalin must be dispensed with a patient Medication Guide containing a guide to the drug’s uses and risks. Angioedema, hypersensitivity reactions, increased seizure frequency, increased suicidal behavior, and peripheral edema are all possible.

“Today’s approval of the first generics for pregabalin, a widely used medication, is another example of the FDA’s long-standing commitment to advance patient access to lower-cost, high-quality generic medicines,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.

lfranki@mdedge.com