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news.Columbia Laboratories and Watson Pharmaceuticals have received the US Food and Drug Administration (FDA) acceptance for submitting Prochieve's (progesterone gel) new drug application (NDA).
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Watson has acquired the progesterone gel from Columbia in July last year.
The product helps to reduce the risk of preterm birth in women with short cervical length.
The NDA 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.
Further, Columbia Labs has voluntarily withdrawn its request for priority review by US health regulators for its vaginal gel.
Columbia Labs president and CEO Frank Condella they look forward to working with the FDA as they review the data package for the Prochieve NDA.
Watson Global Brands executive vice president Fred Wilkinson said the Prochieve NDA 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.