NEW YORK (
has been told by the Food and Drug Administration that data submitted in an application for Lyrica as a monotherapy treatment for generalized anxiety disorder were "insufficient to gain approval."
Pfizer said the application was a resubmission in response to a "not-approvable" letter issued by the FDA in August 2004.
Pfizer said the FDA continues to review a separate application for Lyrica as adjunctive therapy for the treatment of generalized anxiety disorder.
The drugmaker said it was disappointed with the FDA's decision and will work with the agency to determine the next steps.
-- Reported by Joseph Woelfel in New York.
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