Columbia Labs hands over NDA to Watson
Columbia Laboratories (Nasdaq: CBRX) has transferred the 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 (NDA 22-139) to Watson Pharmaceuticals (NYSE: WPI).
Watson has full rights and regulatory responsibility for all activities and sponsor obligations relating to this application as of February 10, 2012. The companies indicated that Watson is continuing to work with Food and Drug Administration in support of the review of the NDA.
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