Progesterone vaginal gel nixed by FDA PARSIPPANY, N.J., Feb. 27 (UPI) -- Officials at the U.S. Food and Drug Administration denied approval for progesterone vaginal gel 8 percent -- used for the reduction of risk of preterm birth. Watson Pharmaceuticals Inc. and Columbia Laboratories Inc. said a letter sent by the FDA stated the progesterone gel, which was to be used in reducing the risk of preterm birth in women with a short uterine cervical length, would not be approved without additional clinical studies. Officials at Watson said on Feb. 10, Columbia transferred the product to them. Watson has full rights and regulatory responsibility for all activities and sponsor obligations relating to the FDA application. Watson will work directly with the FDA to address items raised in the complete response letter regarding the approvability of progresterone vaginal gel 8 percent for reduction of preterm birth. We have formally requested an end of review meeting with FDA to determine if a viable path forward can be established for this application," Paul M. Bisaro, Watson president and chief executive officer, said in a statement. We believe that there is a significant unmet medical need for a safe and effective treatment of patients at risk for preterm birth, which affects approximately one-in-eight live-born infants in the United States.