The Advisory Committee for Reproductive Health Drugs of the US Food and Drug Administration (FDA) is scheduled to meet on January 20, 2012 to review Columbia Laboratories' New Drug Application (NDA) for progesterone vaginal gel for the 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. While the FDA will consider recommendations of the committee, the final decision regarding the approval of the product rests solely with the FDA.

The companies, Columbia Laboratories, Inc. and Watson Pharmaceuticals, Inc. has announced on June 27, 2011 that the FDA accepted the 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 (PDUFA). 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.