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news.Columbia Laboratories has transferred the new drug application (NDA) for progesterone vaginal gel 8% to Watson Pharmaceuticals.
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The product is developed 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.
Watson has gained full rights and regulatory responsibility for all activities and sponsor obligations relating to the application.
Watson will continue to work with FDA in support of the review of the NDA.
Columbia Laboratories president and CEO Frank Condella said they believe this is the appropriate time to transfer the NDA.