Pfizer received a Complete Response letter from the FDA regarding its NDA for Lyrica (pregabalin) capsules CV as a monotherapy treatment for generalized anxiety disorder (GAD). The FDA determined that the data in the NDA were insufficient to support approval. The application was a resubmission in response to a “not-approvable” letter issued by the FDA in August 2004. The FDA continues to review a separate application for Lyrica as adjunctive therapy for the treatment of GAD. “We are disappoin...