Mylan wins FDA approval for generic form of Xanax

Chain Drug Review, Feb 27, 2006

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 figures from IMS Health, Mylan says the brand name product in the same strength recorded sales of $93 million for the year ended in June.

Mylan recently reported results for the third quarter and nine months ended December 31. Revenues for the third quarter of fiscal 2005 increased by 7%, or $20.3 million, to $331.2 million from $291 million in the corresponding period in the preceding year.

Separately, federal regulators have cleared the ANDA of Watson Pharmaceuticals Inc. for testosterone gel 1% CIII. The product is the generic equivalent to Solvay Pharmaceuticals' Andro-Gel, indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Citing figures from IMS Health, Watson notes that for the 12 months ended in November the brand name product had sales of about $330 million in the United States.

Watson points out that it has been awarded 180 days of marketing exclusivity, since it was the first to file an ANDA containing a so-called paragraph IV certification.

Also receiving an ANDA approval was Teva Pharmaceuticals USA. It has introduced desmopressin acetate tablets in 0.1- and 0.2-mg strengths.