Drug Development

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

Published in Health Business Week, July 13th, 2007

Mylan Laboratories Inc. (NYSE:MYL) 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(R) 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...

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Source: Health Business Week (2007-07-13)

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