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Barr Receives Tentative Approval for a Generic Version of Zofran ODT(R) Orally Disintegrating Tablets.
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PR Newswire
- Article date:
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August 27, 2004
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Copyright informationCOPYRIGHT 2004 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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Barr Pharmaceuticals, Inc. today announced that Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of GlaxoSmithKline's Zofran ODT(R) (ondansetron) Orally Disintegrating Tablets, 4mg and 8mg. The Company anticipates receiving final approval and launching its generic product following the expiration of GlaxoSmithKline's patent on June 24, 2006 or following any additional applicable exclusivity.
Barr's Ondansetron Orally Disintegrating Tablets are indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, certain radiotherapies, and the ...