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Mylan Announces Tentative FDA Approval for Ondansetron Orally Disintegrating Tablets, USP.
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PR Newswire
- Article date:
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February 26, 2007
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Copyright informationCOPYRIGHT 2007 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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PITTSBURGH, Feb. 26 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. 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 ...