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FDA Approves Sun Pharma for Generic of Novartis Gleevec

12/04/2015

The US Food and Drug Administration (FDA) has approved Sun Pharmaceutical Industries, the largest drugmaker in India, to manufacture a generic version of Novartis AG’s cancer treatment drug Gleevec.

Used to treat a rare form of blood cancer known as chronic myeloid leukemia, Gleevec was Novartis’ best selling drug last year, contributing $4.7 billion in sales.

Sun Pharma was the first to file an Abbreviated New Drug Application for a generic version of the drug, making them eligible for 180-days marketing exclusivity in the US, the company said in a press release.

The generic version of imatinib mesylate capsules Gleevec is expected to launch in the United States on February 1, 2016.

 

 

 

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