GENERIC MELOXICAM APPROVED QUICKLY THROUGH "CLUSTER REVIEW"

SEPTEMBER 01, 2006

The cost of treating osteoarthritis is likely to drop quickly as a result of the FDA's approval of several first-generic versions of Boehringer Ingelheim's Mobic Tablets (meloxicam). The FDA's approval of generic meloxicam came as a result of a "cluster review" of applications from several manufacturers— an approach designed to cut generic review time at the agency and to enhance the efficiency of the FDA's Office of Generic Drugs (OGD).

At the expiration of a product's 5-year exclusivity, the FDA often receives multiple applications from different generic sponsors, typically all submitted on the same day. Under the new cluster review approach, the OGD will review all of these applications simultaneously.

In the case of meloxicam, the OGD received more than 20 abbreviated new drug applications. The FDA's review resulted in the approval of 13 generic applications for this product in just over 9 months.

"This is another example of our agency's endeavor to counter rising health care costs by approving safe and effective generic alternatives to brand name drugs," said Gary Buehler, director of the OGD. "Meloxicam is a widely used nonsteroidal anti-inflammatory drug, and its generic versions can bring significant savings to the millions of Americans with osteoarthritis."

Because all of the patents for Mobic have expired, the FDA's approval of generic meloxicam "is likely to represent immediate savings to the American public," the agency official said.




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