Columbia Laboratories & Watson Confirm FDA Advisory Committee to Review Preterm Birth NDA
13-Nov-2011
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LIVINGSTON, N.J. and PARSIPPANY, N.J. - Columbia Laboratories Inc. and Watson Pharmaceuticals Inc. confirmed that the Advisory Committee for Reproductive Health Drugs of the US Food and Drug Administration (FDA) is scheduled to review Columbia's 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 on January 20, 2012.
A press release by Watson Pharmaceuticals stated that 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 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.
The FDA will publish materials pertaining to the meeting at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/ucm262537.htm.
Changes to the Advisory Committee meetings calendars may also be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm.
Watson Pharmaceuticals Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health.
Columbia Laboratories Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner.