Sun Pharma Scores FDA Approval for Generic Gleevec

The FDA has given the green light to a Sun Pharmaceutical Industries subsidiary’s imatinib mesylate 100- and 400-mg tablets, a generic version of Novartis’ top-selling drug Gleevec for the treatment of chronic myeloid leukemia.

The unit is the first to file an ANDA for generic Gleevec with a paragraph IV certification, and is eligible for 180-day marketing exclusivity in the U.S. Sun Pharma is planning to launch the copycat on Feb. 1, 2016, after reaching an agreement with Novartis.