Sun Pharma Gets U.S. FDA Nod for Cancer Treatment Drug; Shares Up 4 pct

By siliconindia | Friday, 04 December 2015, 10:13 Hrs

New Delhi: Drug major Sun Pharmaceutical Industries on Friday said one of its subsidiaries has received U.S. FDA approval to manufacture and market generic version of Novartis' Gleevec, used in treatment of cancer, in America.

At 1154 hours the shares of the company were trading up 3.73 pct or 27.10 at 754 per piece on BSE.

In a BSE filing, Sun Pharmaceutical Industries said: "One of its subsidiaries has received final approval from U.S. FDA 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 U.S., 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 (16727.5 crore) in the U.S. These tablets are indicated for the treatment of chronic myeloid leukemia.

Source: PTI