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The U.S. Food and Drug Administration
(FDA) today approved the first generic versions of Ambien (zolpidem
tartrate) immediate-release tablets. Zolpidem (ZOLE-pi-dem) tartrate
is a sedative-hypnotic drug indicated for the short-term treatment
of insomnia.
"The FDA's Office of Generic Drugs ensures that generic drugs are
safe and effective for the American public through a rigorous
scientific and regulatory process," said Gary J. Buehler, director,
Office of Generic Drugs. "This approval offers Americans more
alternatives when choosing their prescription drugs."
Zolpidem tartrate tablets in formulations of five milligrams and
10 milligrams are manufactured by multiple generic drug companies in
the United States. The following 13 manufacturers have received FDA
approval for zolpidem tartrate tablets: Mylan Pharmaceuticals Inc.,
TEVA Pharmaceuticals USA, Roxane Laboratories Inc., Watson
Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy's
Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals Inc.,
Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco
Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek
Pharmaceuticals.
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In March, FDA requested that all manufacturers of
sedative-hypnotic drug products, a class of drugs used to induce
and/or maintain sleep, strengthen their product labeling to include
stronger language concerning potential risks. These risks include
severe allergic reactions and complex sleep-related behaviors, which
may include sleep-driving. Sleep driving is defined as driving while
not fully awake after ingestion of a sedative-hypnotic product, with
no memory of the event. For more information see
www.fda.gov/bbs/topics/
NEWS/2007/NEW01587.html. Generic versions of these drugs will
also include this labeling.
According to the online magazine Drug Topics, in 2006,
Ambien was the 13th highest selling brand name drug. The
sanofi-aventis (formerly Sanofi-Synthelabo, Inc.) patent for
zolpidem tartrate expired on April 21, 2007.
The FDA's Office of Generic Drugs (OGD) reviews and decides on
approval of generic drug applications. For more information on other
first generic versions, please see
http://www.fda.gov/cder/ogd/approvals/.
For more information about generic drugs, please see the FDA
Consumer article, Generic Drugs: What You Need to Know
at
www.fda.gov/fdac/features/
2002/502_generic.html. For additional information related to
FDA's Office of Generic Drugs, please see:
www.fda.gov/cder/consumerinfo/
generic_equivalence.htm.
[Text copied
from U.S. Food and Drug Administration
news release]
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