First Generics of Lyrica Get FDA Approval

The Food and Drug Administration has approved the first generics of Lyrica (pregabalin; Pfizer) capsules.

Pregabalin, a gabapentinoid, is indicated for the management of: 

• Neuropathic pain associated with diabetic peripheral neuropathy
• Neuropathic pain associated with spinal cord injury
• Postherpetic neuralgia
• Fibromyalgia

The generic version is also approved as an adjunctive therapy for partial-onset seizures in patients 17 years of age and older. 

“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 the FDA’s Center for Drug Evaluation and Research. 

Applicants that received approval to manufacture pregabalin capsules include InvaGen Pharmaceuticals, Rising Pharmaceuticals, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, Msn Laboratories, Sciegen Pharmaceuticals, Alkem Laboratories, Alembic Pharmaceuticals, and Teva Pharmaceuticals. The generic product will be available in 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg strengths.

For more information visit FDA.gov.