Generic pregabalin capsules receive FDA approval

August 1, 2019 0 By FM

The U.S. Food and Drug Administration has approved multiple applications for first generics of Lyrica (pregabalin).

Pregablin is administered for the management of neuropathic pain associated with diabetic peripheral neuropathy, for management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.

The FDA granted approvals for the generic versions of Lyrica 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.

“The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.” says Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.