FDA News
 FOR IMMEDIATE RELEASE
 P06-100
 July 19, 2006 Media Inquiries:
 Laura Alvey, 301-827-6242
 Consumer Inquiries:
 888-INFO-FDA

FDA Approves First Generic Meloxicam

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.

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