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...
To view the full article, register now.

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.