FDA panel gives thumbs down to Columbia Labs reproductive drug

FDA Reproductive Health Drugs Advisory Committee declines to recommend approval of progesterone vaginal gel

PARSIPPANY, N.J. — A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

Columbia Labs and Watson Pharmaceuticals announced that the FDA's Reproductive Health Drugs Advisory Committee did not recommend approval for progesterone vaginal gel in the 8% strength. The drug is designed to reduce the risk of preterm birth in women with short uterine cervical length in the middle trimester of pregnancy.

The FDA takes advisory committees' recommendations into account when deciding whether to approve a drug, and while the recommendations are not binding, the agency doesn't usually go against them. The FDA's Division of Reproductive and Urologic Products is expected to take action on the drug by Feb. 26. Nevertheless, Columbia president and CEO Frank Condella said the company was confident that a late-stage clinical trial of the drug showed it to be safe and effective.


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