Sun Pharma gets USFDA approval for anti-cancer drug Gleevec

Gleevec tablets are used for the treatment of chronic myeloid leukemia - a rare form of blood cancer The Dollar Business Bureau

The Sun Pharma subsidiary was the first to file an ANDA for generic Gleevec with a para IV certification for 180-days marketing exclusivity in the US.

Sun Pharmaceutical Industries Ltd. on Friday announced that 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 100mg and 400mg. “Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis’ Gleevec tablets,” Sun Pharmaceutical said in a statement. Gleevec tablets are used for the treatment of chronic myeloid leukemia - a rare form of blood cancer. These tablets have annual sales of approximately $2.5 billion in the US, as per IMS MAT August 2015. The Sun Pharma subsidiary was the first to file an ANDA for generic Gleevec with a para IV certification for 180-days marketing exclusivity in the US. A part of the agreement with Novartis, Sun Pharma subsidiary has been permitted to launch its version of generic Gleevec in the USA on February 1, 2016.

November 04, 2015 | 3:18pm IST.

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The Dollar Business Bureau - Dec 04, 2015 09:48 IST

Sun Pharma gets USFDA approval for anti-cancer drug Gleevec

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