Watson Pharmaceuticals, Inc. (WPI) Thursday said the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration is scheduled to review Columbia Laboratories, Inc.'s (CBRX) New Drug Application for progesterone vaginal gel on January 20, 2012.
The gel is for reduction of risk of preterm birth in women with short uterine cervical length regardless of other risk factors in the mid-trimester of pregnancy.
The Advisory Committee for Reproductive Health Drugs is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of reproductive conditions and makes non-binding recommendations to the FDA.
The companies announced on June 27, 2011 that the FDA accepted the New Drug Application or NDA for filing. The FDA's goal is to review and act on the NDA by February 26, 2012 under the Prescription Drug User Fee Act IIII.
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.
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