FDA APPROVED ZOLPIDEM TARTRATE
FDA News
FOR IMMEDIATE RELEASE
P07-72
April 23, 2007
Media Inquiries:
Sandy Walsh, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Approves First Generic Versions of Ambien (Zolpidem Tartrate)
for the Treatment of Insomnia
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.
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.
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