Pfizer Inc. (NYSE: PFE) announced that the Food and Drug Administration (FDA) issued a Complete Response letter regarding the company’s New Drug Application (NDA) for Lyrica® (pregabalin) capsules CV as a monotherapy treatment for generalized anxiety disorder (GAD). The FDA determined that the data contained in the NDA were insufficient to support approval. The application [...]

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, announced that the company has received a Complete Response Letter from the U.S. Food and Drug [...]

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, [...]

Dendreon Corporation (Nasdaq: DNDN) announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company’s amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon’s [...]

Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a focus on oncology, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the Company’s supplement to the biologics license application for ZEVALIN (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. [...]