Healthcare Industry News:  Mylan Laboratories 

Biopharmaceuticals Generics FDA

 News Release - June 25, 2007

Mylan Announces Final FDA Approval for Ondansetron Hydrochloride Tablets and Ondansetron Orally Disintegrating Tablets, USP

PITTSBURGH, June 25 (HSMN NewsFeed) -- Mylan Laboratories Inc. (NYSE: MYL ) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for Ondansetron Hydrochloride (HCl) Tablets, 4 mg (base), 8 mg (base) and 24 mg (base), and Ondansetron Orally Disintegrating Tablets (ODT) USP, 4 mg and 8 mg.

Ondansetron HCl Tablets are the generic version of GlaxoSmithKline's Zofran® Tablets. Ondansetron HCl Tablets had U.S. sales of approximately $744 million for the same strengths for the 12-month period ending March 31, 2007, according to IMS Health.

Ondansetron ODT are the generic version of GlaxoSmithKline's Zofran ODT® Tablets. Ondansetron ODT had U.S. sales of approximately $348 million for the same strengths for the 12-month period ending March 31, 2007, according to IMS Health.

These products will be shipped immediately.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.

For more information about Mylan, please visit http://www.mylan.com.


Source: Mylan Laboratories

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