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Dr Reddy’s and Fresenius Kabi get US FDA approval for generic Femara

The US Food and Drug Administration gave approval to Dr Reddy’s Laboratories and Fresenius Kabi Oncology, both listed Indian pharmaceutical companies, to market cancer drug letrozole or the generic version of Femara in the US. Novartis owns the patent for Femara, a drug used to treat breast cancer in post-menopausal women, which earned US-market sales of $682 million or Rs 3,100 crore in 2010.

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Natco Pharma gets first-to-file on generic Tamiflu

Natco Pharma, an Rs 440 crore turnover pharmaceutical company, has challenged the US patent on Tamiflu held by Gilead Sciences, and licensed to F. Hoffmann-La Roche in 1996. Both Natco and Gilead announced this in separate statements. Natco said that the FDA has accepted its abbreviated new drug application (ANDA) for generic Tamiflu or oseltamivir phosphate.

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