FDA declines to approve Watson reproductive drug

Agency issues complete response letter for progesterone vaginal gel

PARSIPPANY, N.J. — The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.

The FDA sent the companies a complete response letter for their progesterone vaginal gel in the 8% strength. The drug is used to reduce the risk of preterm birth in women with singleton gestation and short uterine cervical length in the second trimester of pregnancy. Columbia transferred rights to the drug to Watson earlier this month, leaving Watson with full responsibility for obtaining regulatory approval.

The FDA said in the letter that results from a clinical trial of the drug did not show the levels of statistical significance that the agency requires for approval of a drug after a single late-stage clinical trial and that it would require additional clinical trial data before it could approve it.


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