In a BSE filing, Sun Pharmaceutical Industries said: "One of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets."

The subsidiary, being the first-to-file an ANDA for generic Gleevec with a para IV certification, is eligible for 180-days marketing exclusivity in the US, the company said.

The commercial launch of this product is scheduled for February 1, 2016.

Quoting IMS data, the company said as on August 2015, these tablets have annual sales of approximately USD 2.5 billion in the US.

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