FDA Gives Mylan Tentative OK On Generic Femara

Law360, New York (May 3, 2007, 12:00 AM EDT) -- Mylan Pharmaceuticals Inc. has moved closer to regulatory approval to make generic Femara, the drug maker said Thursday, raising the stakes in a patent infringement suit Germany’s Novartis AG filed to protect the popular breast cancer treatment.

In a statement, Mylan said its Abbreviated New Drug Application to manufacture 2.5 mg tablets of letrozole, the active ingredient in the drug, had received tentative approval from the U.S. Food and Drug Administration.

The development advanced Mylan’s plan to cut into Novartis’ U.S. sales for 2.5 mg Femara...
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