GENERIC AMBIEN
The FDA approved on the April 23, 2007 the
first generic versions of Ambien (zolpidem tartrate)
immediate-release tablets. It is said that 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.
So, Ambien is brand name for Zolpidem
tartrate, a sedative-hypnotic drug used for the short-term
treatment of insomnia.
According to the online magazine Drug Topics
Ambien was the 13th best selling brand name drug in 2006.
"This approval offers Americans more alternatives when
choosing their prescription drugs," said Gary J. Buehler,
director of the FDA's Office of Generic Drugs.
Zolpidem tartrate tablets in formulations
of 5 milligrams and 10 milligrams are manufactured by a variety
of generic drug companies in the United States. Thirteen manufacturers
have received FDA approval to manufacture zolpidem tartrate
tablets.
The following 13 manufacturers have received FDA approval
for zolpidem tartrate tablets: Mylan Pharmaceuticals, TEVA
Pharmaceuticals USA, Roxane Laboratories, Watson Laboratories,
Ranbaxy Laboratories, Dr. Reddy’s Laboratories, Apotex,
Synthon Pharmaceuticals, Genpharm, Mutual Pharmaceutical Company,
Caraco Pharmaceutical Laboratories, Carlsbad Technology, and
Lek Pharmaceuticals.
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