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.