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news.The US Food and Drug Administration's (FDA) Advisory Committee for Reproductive Health Drugs is set to review Columbia Laboratories' New Drug Application (NDA) of progesterone vaginal gel on 20 January 2012.
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The progesterone vaginal gel is used to reduce the risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.
The NDA includes data from two Phase III clinical trials evaluating the use of progesterone vaginal gel in reducing the risk of preterm birth in women, as well as supportive pharmacokinetic studies.
The FDA’s goal is to review and act on the NDA by 26 February 2012 under the Prescription Drug User Fee Act IIII (PDUFA).