Columbia Laboratories NDA for PROCHIEVE Gel Accepted for Filing by FDA

Columbia Laboratories, Inc. CBRX and Watson Pharmaceuticals, Inc. WPI today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Columbia's New Drug Application for PROCHIEVE® (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. The acceptance of the NDA for filing means FDA has determined that the application is sufficiently complete to permit a substantive review. The acceptance for filing does not provide any assurance that the FDA will ultimately approve the NDA. In addition, Columbia has voluntarily withdrawn its request for priority review. Following discussions with FDA, the companies determined that a standard review would afford the agency the appropriate timeframe necessary to complete its review of the application, including empaneling an agency advisory committee, if necessary. Under the Prescription Drug User Fee Act III (PDUFA), the FDA's goal under standard review is to review and act on the NDA by February 26, 2012.