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FDA approves first generics of Pfizer blockbuster, Lyrica

26th, July, 2019
FDA approves first generics of Pfizer blockbuster, Lyrica

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. On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin): for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the 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.

It was developed as a successor to Gabapentin. Gabapentin and Lyrica are both anticonvulsant medications used to treat seizures, post-herpetic neuralgia (pain from shingles), and certain other types of neuropathic pain. Both drugs also have some potential for abuse and the development of physical dependence. In terms of differences, Lyrica appears to be more rapidly absorbed, may be relatively more effective for certain treatments, and produces fewer side effects. In 2016, it was the 83rd most prescribed medication in the United States with more than 9 million prescriptions. In the US, Pregabalin is a Schedule V controlled substance under the Controlled Substances Act of 1970.

Original content: https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-lyrica