Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%; Says Gel is Reducing Risk, but Did Not Meet The Level of Statistical Significance

Watson Pharmaceuticals, Inc. WPI and Columbia Laboratories, Inc. CBRX today confirmed that, as expected, Watson has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA 22-139) for progesterone vaginal gel 8% for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy. The complete response letter stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at Market News and Data brought to you by Benzinga APIs

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