FDA makes Gleevec Generic
FDA makes Gleevec Generic

A most commonly prescribed cancer drug in the market has been made generic by the US Food and Drug Administration (FDA) after the generic drug maker and the brand-name has brought its dispute over patents to end past year.

A request made by India based Sun Pharmaceutical Industries Limited subsidiary for the production of a generic version of Gleevec (imatinib mesylate) has got the FDA approval. Gleevec is generally prescribed medication for patients who have chronic myeloid leukemia (CML). It is also called chronic myelogenous leukemia, and is steadily progressive, though it can transform into an acute type also.

CML generally occurs in adults, but the treatment is same for both children and adults. According to American Cancer Society, Novartis-produced-Gleevecis is considered as better performing as compared to interferon, which was once the most prescribed medication. The drug can also be used for the treatment acute lymphoblastic leukemia.

The subsidiary is looking forward to produce generic version of Gleevec in 100 and 400 milligrams, both, which can be consumed once a day. They can start the distribution of the cancer drug by February 2016’s first week. After 180 days, the FDA will review and decide whether other generic drug makers will be permitted to make their own or not.

Dr Reddy's Laboratories Limited is among the possible candidates. It has reached on a deal with Novartis over patents. According to analysts they could start launching in the 2016’s last quarter.




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