The Food and Drug Administration has approved the first generic versions of Boehringer Ingelheim's Mobic Tablets. Meloxicam is used for the treatment of osteoarthritis. Gary Buehler, director of the Office of Generic Drugs, says, "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."
He adds, "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, a new method instituted by the FDA to facilitate the review of generic drug applications. FDA's Office of Generic Drugs has been reviewing groups of applications submitted at the end of a 5-year new chemical entity exclusivity in "clusters" to increase efficiency and decrease review time