Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA) was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.

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, [...]

Transcept Pharmaceuticals (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of [...]