FDA Approves Nine Generic Versions of Lyrica

July 22, 2019
Pharmaceutical Technology Editors

The first generics of Lyrica have been approved by the FDA for neuropathic pain management and adjunctive therapy.

The FDA announced it has approved the first generics of Pfizer’s Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, spinal cord injury, and postherpetic neuralgia, according to a July 22, 2019 FDA press statement. 

 The drug also can be used as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older. 

Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals received approvals to produce generic versions of the blockbuster drug.

Common side effects associated with Lyrica include swelling of the throat, head, and neck, hypersensitivity reactions, increased risk of suicidal thoughts and behavior, dizziness, somnolence, dry mouth, blurred vision, weight gain, and abnormal thinking.. 

"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, director of the FDA's Center for Drug Evaluation and Research, in the press statement. "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."  

Source: FDA