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Watson Receives Complete Response Letter from FDA for Progesterone Vaginal Gel 8%
Date:2/27/2012

PARSIPPANY and LIVINGSTON, N.J., Feb. 27, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) and Columbia Laboratories, Inc. (Nasdaq: 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 </= 32 6/7 weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial.  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.

On February 10, 2012, Columbia transferred NDA 22-139 to Watson.  Watson now has full rights and regulatory responsibility for all activities and sponsor obligations relating to this 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% 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," said Paul M. Bisaro, Watson
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SOURCE Watson Pharmaceuticals, Inc.
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