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

President and CEO.  "We believe that there is a significant unmet medical need for a safe and effective treatment of patients at risk for preterm birth which affects approximately one-in-eight live-born infants in the U.S."

Data submitted to the FDA in support of approval of NDA 22-139 included results from the PREGNANT study, which showed that women with a short uterine cervical length as measured by trans-vaginal ultrasound between 19 and <24 weeks of gestation who were treated with progesterone vaginal gel 8% had a significantly lower risk of preterm birth at </= 32 6/7 weeks gestation compared to those who were treated with placebo (p=0.022). This study included women with and without a prior history of preterm birth.  Progesterone vaginal gel 8% was also associated with a significant reduction in the risk of preterm birth at </= 34 6/7 weeks gestation (p=0.012).

In the PREGNANT study, the frequency of maternal treatment-emergent adverse events both overall and by individual event was comparable between the placebo and progesterone vaginal gel treatment groups. The most frequent events in the progesterone vaginal gel group were expected complications of a high-risk pregnancy and included "premature baby" (19%), "uterine contractions abnormal" (14%), "premature labor" (7%). "Cervical disorder" (10%), "nausea" (10%), "headache" (7%), and "vulvo vaginal mycotic infection" (7%) were also reported.

About Watson PharmaceuticalsWatson Pharmaceuticals, Inc., is a leading integrated global pharmaceutical company. The Company is engaged in the development, manufacturing 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 '/>"/>

SOURCE Watson Pharmaceuticals, Inc.
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