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FDA Issues Approvable Letters for Pregabalin for Three Indications
NEW YORK, September 2, 2004 -- In response to media inquiries, Pfizer said it has received approvable letters from the US Food & Drug Administration for three indications for Lyrica (pregabalin): neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and as adjunctive therapy in the treatment of partial seizures in adults. Pfizer received a non-approvable letter for Lyrica for the treatment of generalized anxiety disorder.
Pfizer said it is continuing to work closely with the FDA during the ongoing regulatory review to resolve open issues on all indications and labeling.
In the European Union, Lyrica received marketing approval in July 2004 for the management of peripheral neuropathic pain and as an adjunctive therapy in the treatment of partial seizures.