Thursday, December 3, 2015

#Sun Pharma gets #USFDA approval for generic cancer drug #Gleevec

The US subsidiary of Sun Pharma  has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets 100mg and 400mg.

The company is eligible for 180-days marketing exclusivity in the US. Under the terms of a settlement agreement with Novartis Pharmaceuticals Corporation, the company is permitted to launch its version of generic Gleevec in the United States on February 1, 2016.

Gleevec is used in treatment of chronic myeloid leukemia.Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis’ Gleevec tablets. As per IMS MAT August 2015, these tablets have annual sales of approximately US$ 2.5 billion in the US.