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Mylan gets FDA nod for generic Zofran


Published :
Mon, 25 Jun 2007 23:58
By : Agencies
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PITTSBURGH (AP) - Drug developer Mylan Laboratories Inc. the Food and Drug Administration approved its generic version of GlaxoSmithKline Plc's anti-nausea drug Zofran.

The drug is given to cancer patients undergoing chemotherapy to prevent vomiting. Patents on Zofran began expiring in December. Mylan said it plans on shipping its generic version of the drug immediately.

Mylan received approval for two forms of the drug: Ondansetron hydrochloride tablets in 4-milligram, 8-milligram, and 24-milligram doses and for ondansetron orally disintegrating tablets in 4-milligram and 8-milligram doses.

In 2005, Zofran had sales of $1.6 billion.

Several other drug companies have also received approval for generic Zofran, including Indian drug developer Dr. Reddy's Laboratories Ltd., Teva Pharmaceutical Industries, Hospira Inc. and Par Pharmaceuticals.

Shares of Mylan fell 25 cents to $18.65 Monday, while GlaxoSmithKline shares lost 17 cents to $51.66.

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Questions or comments about this story should be directed to Damian J. Troise at 212-621-7190

Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.




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