FDA tells Pfizer its Lyrica GAD data insufficient

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Pfizer Inc. said Wednesday it has been told by regulators that the data submitted in its application for the use of its drug Lyrica as a stand-alone treatment for generalized anxiety disorder were insufficient to gain approval.

Pfizer Inc. said Wednesday it has been told by regulators that the data submitted in its application for the use of its drug Lyrica as a stand-alone treatment for generalized anxiety disorder were insufficient to gain approval.

The drugmaker said the Food and Drug Administration's decision came after Pfizer resubmitted its application in response to a "not-approvable" letter issued by the FDA in August 2004.

The FDA is still reviewing a separate application for Lyrica as adjunctive therapy for the treatment of general anxiety disorder, Pfizer said.

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