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 The leading web portal for pharmacy resources, news, education and careers November 20, 2009
Pharmacy Choice - Pharmaceutical News - FDA OKs Mylan generic version of transplant drug - November 20, 2009

Pharmacy News Article

 5/7/09 - FDA OKs Mylan generic version of transplant drug

PITTSBURGH-Generic drug maker Mylan Inc. said Thursday federal regulators approved its application to make generic versions of the Roche drug CellCept, which prevents organ rejection in some transplant patients.

The Food and Drug Administration approved Mylan's abbreviated new drug applications for 500-milligram tablets and 250-milligram capsules of the drug. CellCept helps prevent organ rejection in patients receiving kidney, heart or liver transplants.

Mylan said the two versions of the drug brought in a combined total of more than $1 billion in sales in the 12 months that ended March 31.

The drug developer has started shipping both products.

Mylan's shares rose 3.6 percent, or 48 cents, to $13.75 in Thursday morning trading.



(c) 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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