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Mylan Announces Final FDA Approval for Ondansetron Hydrochloride Tablets and Ondansetron Orally Disintegrating Tablets, USP |
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26 Jun 2007 |
Mylan Laboratories Inc. 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
PITTSBURGH, PA, USA | June 25, 2007 | 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(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 GlaxoSmithKline's Zofran ODT(R) 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 Inc |
