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FDA gives tentative approval to generic breast cancer treatment


ROCKVILLE, Md. The Food and Drug Administration has given tentative approval to a generic drug for treating breast cancer.

The drug, Roxane Labs’ letrozole tablets in the 2.5 mg strength, is a generic version of Novartis’ Femara.

Femara had global sales of $1.13 billion in 2008, according to Novartis financial data. Novartis’ patent on the drug will expire in 2011, according to the FDA’s Orange Book.

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