FDA issues complete response for Prochieve

Watson Pharmaceuticals Inc. (NYSE:WPI) said it received a complete response letter from FDA for an NDA for Prochieve vaginal progesterone gel to reduce the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. According to Watson, FDA said additional clinical testing would be required to support approval. Watson requested a meeting with the agency to determine next steps. In January, an FDA panel voted 13-4 that the benefit-risk profile of Prochieve does not support its approval (see BioCentury, Jan. 20). ...