FDA approves first generic meloxicam

July 20, 2006 at 10:12 AM
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WASHINGTON, July 20 (UPI) -- The U.S. Food and Drug Administration says it has approved several generic versions of the Boehringer Ingelheim Corp.'s Mobic tablets also known as meloxicam.

The action is seen as a major step in the effort to increase availability of lower-cost generic medications. Meloxicam is indicated for the treatment of osteoarthritis.

The approval of meloxicam was the result of a "cluster" review, in which the FDA reviews groups of applications submitted at the end of 5-year new chemical entity exclusivity periods. The new review program is designed to increase efficiency and decrease review time, the agency said. At the expiration of the 5-year exclusivity, FDA receives multiple applications from different sponsors, submitted on the same day.

In the case of meloxicam, the FDA's Office of Generic Drugs said it received more than 20 applications, with the new review process resulting in approval of 13 generic applications in little more than 9 months of review time, resulting in the first time any generic version of the product has been made available.

In 2005, Drug Topics online magazine ranked Mobic 38th in U.S. sales of brand-name drugs, with sales totaling $916 million.

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