Watson Gets FDA's Complete Response Letter For Progesterone Vaginal Gel 8%

Watson Pharmaceuticals, Inc. (WPI) and Columbia Laboratories, Inc. (CBRX) confirmed that, as expected, Watson has received a complete response letter from the FDA for its New Drug Application 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

Although not part of the requirements communicated to the sponsor during pre-Phase III meetings, the FDA also raised the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial. In the complete response letter, FDA stated that additional clinical work would be required to support the approval.

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