FDA Panel Turns Down Columbia, Watson Preterm Birth Gel

Law360, New York (January 23, 2012, 5:33 PM EST) -- Columbia Laboratories Inc. and Watson Pharmaceuticals Inc. hit a potential setback on Friday when a U.S. Food and Drug Administration advisory committee recommended against approving their vaginal gel product for preterm labor prevention.

While the FDA won't necessarily follow the recommendation of the Advisory Committee for Reproductive Health Drugs to reject the progesterone gel, the committee's request for additional information on the product's efficacy in U.S. patients could make the road to approval more rocky.

The gel is already marketed in the U.S. by the New...
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