The FDA has given Mylan Laboratories tentative approval for its abbreviated new drug application for a 2.5mg generic version of Novartis' breast cancer drug Femara.
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Femara tablets had US sales of approximately $326 million for the same strength for 2006, according to IMS Health.
However, Novartis plans to defend its intellectual property rights against Mylan, according to Reuters. Novartis has a compound patent on Femara until 2011 and filed a patent infringement lawsuit against Mylan’s generic version in 2006.