Mylan Receives Final FDA Approvals for Generic Versions of Anti-RejectionMedication CellCept(R)

Thu, 05/07/2009 - 4:39am
Mylan Inc. hasannounced that its subsidiary Mylan Pharmaceuticals Inc. received finalapprovals from the U.S. Food and Drug Administration (FDA) for its AbbreviatedNew Drug Applications (ANDAs) for Mycophenolate Mofetil Tablets, 500 mg, andMycophenolate Mofetil Capsules, 250 mg. Mycophenolate Mofetil is the generic name for Roche's CellCept(R), whichis indicated for the prevention of organ rejection in patients receivingkidney, heart or liver transplants. CellCept Tablets, 500 mg, and CellCeptCapsules, 250 mg, had annual U.S. sales of approximately $680 million and $367million, respectively, for the 12 months ending March 31, 2009, according toIMS Health. Mylan has commenced shipping both products.

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