|
|
Article: Mylan wins FDA approval for generic form of Xanax.(Mylan Laboratories Inc., Food and Drug Administration )(Brief Article)
- Article from:
- Chain Drug Review
- Article date:
- February 27, 2006
CopyrightCOPYRIGHT 2006 Racher Press, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
WASHINGTON -- The Food and Drug Administration has approved the abbreviated new drug application (ANDA) of Mylan Laboratories Inc. to market a generic version of Xanax XR. Pfizer Inc. manufactures the brand name panic-disorder treatment.
Known under its generic name of alprazolam, the brand product had sales of about $100 million for the 12 months ending in June.
Mylan's extended-release tablets will be available in 0.5-, 1-, 2- and 3-mg strengths.
The company has also won approval for a generic muscle relaxant. Mylan has been given regulatory clearance for cyclobenzaprine hydrochloride tablets, 5 mg, the equivalent to Flexeril (McNeil). Citing ...