Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%; Says Gel is Reducing R

Watson Pharmaceuticals, Inc. (NYSE:

) and Columbia Laboratories, Inc. (Nasdaq:

) 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

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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