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Mylan Announces Tentative FDA Approval for Ondansetron Orally Disintegrating Tablets, USP |
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27 Feb 2007 |
Announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Orally Disintegrating Tablets USP, 4mg and 8mg strengths.
PITTSBURGH, PA, USA | Feb 26, 2007 | Mylan Laboratories Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Orally Disintegrating Tablets USP, 4mg and 8mg strengths.
Ondansetron Orally Disintegrating Tablets are the generic version of GlaxoSmithKline's Zofran ODT(R) Tablets, which had U.S. sales of approximately $314 million for the same strengths for the 12-month period ending Dec. 31, 2006, according to IMS Health.
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 www.mylan.com.
SOURCE Mylan Laboratories Inc |
