FDA Approves Multiple Applications for Generic Version of Lyrica
July 22 2019 - 11:36AM
Dow Jones News
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
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