Chain Drug Review - Mylan wins FDA approval for generic form of Xanax.(Mylan Laboratories Inc., Food and Drug Administration )(Brief Article)
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.
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The company has also won approval for a generic muscle relaxant. Mylan has been given regulatory clearance for cyclobenzaprine …
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