Meloxicam is a
widely-used nonsteroidal anti-inflammatory drug (NSAID) used for
osteoarthritis
and and in 2006 the generic version became available.
Generic Meloxicam
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 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 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, meloxicam was ranked 38th in dollar sales
of brand-name drugs in the United States, with sales totaling close to a billion
dollars.