FDA Consumer - Generic drugs for osteoarthritis
The FDA has approved several generic versions of Boehringer Ingelheim’s Mobic (meloxicam) tablets. Meloxicam is indicated for the treatment of osteoarthritis.
“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,” Gary Buehler, director of the FDA’s Office of Generic Drugs (OGD), said in announcing the July 2006 approval. “Meloxicam is a widely-used nonsteroidal anti-inflammatory drug (NSAID), and its generic versions can bring significant savings to the millions of Americans with osteoarthritis.”
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The approval of meloxicam was the result of a “cluster” review approach, one of the process improvements the FDA has instituted to facilitate the review of generic drug applications. The OGD has begun to review groups of applications submitted at the end of five-year new chemical entity (NCE) exclusivity in “clusters” to increase efficiency and decrease review time. At the expiration of five-year exclusivity, the FDA often receives multiple applications from different sponsors, submitted on the same day.
In the case of meloxicam, the OGD received more than 20 Abbreviated New Drug Applications (ANDAs), and efforts of the FDA’s review team resulted in approval of 13 generic applications for this product in a little over nine months of review time. This is the first time that any generic version of this product has been available.
Because all the patents have expired for Mobic, approval of meloxicam is likely to represent immediate savings to the American public. In 2005, Mobic was ranked 38th in dollar sales of brand-name drugs in the United States, with sales totaling $916,397,000, according to the online magazine, Drug Topics.
Generic drugs are used to fill more than 50 percent of all prescriptions. Because they can cost a fraction of the price of brand-name drugs, the economic impact of the FDA’s generic drug program is significant. With this in mind, the OGD continues working expeditiously to review and take action on generic drug applications.
COPYRIGHT 2006 U.S. Government Printing Office
COPYRIGHT 2008 Gale, Cengage Learning
