FDA Approves First Generic Meloxicam
July 19, 2006
The Food and Drug Administration today approved several first generic versions of Boehringer Ingelheim’s Mobic Tablets, an important step in the agency’s effort to increase the availability of lower-cost generic medications. Meloxicam (mel-OX-i-kam) 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," said Gary Buehler, Director, Office of Generic Drugs. "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."
The approval of meloxicam was the result of a “cluster” review approach, one of the process improvements FDA has instituted to facilitate the review of generic drug applications. FDA’s Office of Generic Drugs (OGD) has begun to review groups of applications submitted at the end of 5 year new chemical entity (NCE) exclusivity in “clusters” to increase efficiency and decrease review time. At the expiration of 5 year exclusivity, FDA often receives multiple applications from different sponsors, submitted on the same day.
In the case of meloxicam, OGD received over 20 abbreviated new drug applications (ANDAs) and FDA’s review team effort resulted in the approval of 13 generic applications for this product in a little over 9 months of review time, resulting in the first time any generic version of this product is available.
Because all of the patents have expired for Mobic, approval of meloxicam is likely to represent immediate savings to the American public. In 2005, according to the online magazine, Drug Topics, Mobic was ranked 38th in dollar sales of brand-name drugs in the United States, with sales totaling $916,397,000.
Generic drug products are used to fill over 50 percent of all prescriptions and because they can cost a fraction of the price of brand name drugs, the economic impact of FDA’s generic drug program is significant. With this in mind, the Office of Generic Drugs (OGD) continues working expeditiously to review and take action on generic drug applications as quickly as possible.
For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm.
For additional information related to FDA’s Office of Generic Drugs, please go to: http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm.
Posted: July 2006