First Generic Version of Gleevec Approved by FDA

From the WebMD Archives

Dec. 7, 2015 -- The first generic version of the cancer drug Gleevec (imatinib mesylate) has been approved by the U.S. Food and Drug Administration.

The agency approved 100-milligram and 400-milligram pills of the generic version to treat chronic myeloid leukemia. The once-a-day pills are made by Sun Pharmaceutical Industries Ltd. of India, which said U.S. sales of the pills will begin Feb. 1, 2016, the Associated Pressreported.

The FDA gave Sun exclusive rights to sell generic Gleevec for six months. If the FDA approves other drug companies' generic versions, there should be a significant drop in the cost.

Gleevec -- sold by Novartis -- costs about $10,000 a month for the 400-milligram daily dosage. Novartis is trying to limit the number of U.S. patients who start using the generic version by offering patients with private insurance discount cards that cap their monthly co-payment at $10, with the drug company paying up to $30,000 a year of the pharmacy tab. Insurers would have to cover the rest of the bill, the AP reported.

Patients who pay cash or those with government coverage are not eligible.

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