Columbia Labs (CBRX) NDA for PROCHIEVE Accepted by U.S. FDA
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Columbia Laboratories, Inc. (Nasdaq: CBRX) and Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Columbia's New Drug Application (NDA) 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.
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.
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