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Columbia Laboratories' NDA for PROCHIEVE® Vaginal Progesterone Gel Accepted for Filing by FDA
Date:6/27/2011

for preventing preterm birth in women with premature cervical shortening, an emerging risk factor," said Fred Wilkinson, Watson's Executive Vice President, Global Brands.  "The PROCHIEVE New Drug Application represents an important step in the evaluation of a potential new treatment, and if approved, could have a meaningful impact on mothers and the health of their babies, as well as a significant economic impact on the healthcare system."

Columbia submitted the NDA, which includes data from two Phase III clinical trials evaluating the use of PROCHIEVE in reducing the risk of preterm birth in women, as well as supportive pharmacokinetic studies, to the FDA on April 26, 2011.  

About Watson PharmaceuticalsWatson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.

For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.

About Columbia LaboratoriesColumbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company has developed and sold six products for the U.S. market including CRINONE® (progesterone gel) for which Columbia receives royalties on annual net sales from Watson Pharmaceuticals. CRINONE is commercialized outside the U.S. by Merck Serono.

Columbia's press releases and other company information are available online at http://www.columbialabs.com.

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