FDA approves nine generic versions of Pfizer’s Lyrica
pharmafile | July 23, 2019 | News story | Manufacturing and Production, Sales and Marketing | FDA, Lyrica, Pfizer, pharma
The FDA has given its approval to the first generic versions of Pfizer’s Lyrica (pregabalin), it has emerged, giving the commercial green light to not one, but nine different analogue therapies.
The US regulator awarded marketing approval to generic products from Teva, Dr Reddy’s Laboratories, Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals and Sciegen Pharmaceuticals.
The products were indicated in the same treatment areas as their reference therapy, including for the management of fibromyalgia, neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia as an adjunctive therapy for the treatment of partial onset seizures, and for neuropathic pain associated with spinal cord injury.
Lyrica was originally approved by the FDA back in 2004 and has gone on to become one of Pfizer’s best-selling drugs; the therapy generated $4.6 billion last year alone. While Pfizer’s branded version costs between $460 and $720, the approved generic versions comparably cost between $140 and $370.
“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 Dr Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research. “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.”
Matt Fellows
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