FDA Approves Multiple Applications for Generic Version of Lyrica

By Chris Wack

The U.S. Food and Drug Administration on Monday said it approved multiple applications for the first generics of Lyrica, or pregabalin, for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, and neuropathic pain associated with spinal cord injury.

The FDA granted approvals for the generic versions of Lyrica to Alembic Pharmaceuticals (533573.BY), Alkem Laboratories (539523.BY), Amneal Pharmaceuticals (AMRX), Dr. Reddy's Laboratories (RDY), InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals (TEVA).

The FDA said the approval of the first generics for pregabalin advances patient access to lower cost, high-quality generic medicines.

The most common side effects reported in the clinical trials for Lyrica in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and abnormal thinking.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

July 22, 2019 11:21 ET (15:21 GMT)

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