Sun Pharma gets USFDA nod for generic form of Novartis' Gleevec

Drug major Sun Pharmaceutical Industries today said one of its subsidiaries has received USFDA approval to manufacture and market generic version of Novartis' Gleevec, used in treatment of cancer, in America.

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

"The approval has been granted for Imatinib Mesylate tablets of 100 mg and 400 mg strengths. Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis' Gleevec tablets," it added.

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.

"Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the United States on February 1, 2016," it added.

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 $2.5 billion in the US.

These tablets are indicated for the treatment of chronic myeloid leukemia.

Sun Pharma shares were trading 3.95 per cent up at Rs 755.60 apiece during morning session on BSE.