FDA OKs first generic for Gleevec leukemia pill
U.S. regulators have approved a generic version of one of the first very effective — and expensive — cancer drugs, Gleevec (GLEE'-vek).
The Food and Drug Administration granted a subsidiary of Indian drugmaker Sun Pharmaceutical Industries Ltd. approval to sell generic Gleevec pills, known chemically as imatinib mesylate, in 100-milligram and 400-milligram doses for chronic myeloid leukemia.
Sun Pharmaceutical, one of the world's biggest makers of generic medicines, says it will begin selling the pills in the U.S. on Feb. 1, 2016.
Gleevec, which was developed and is sold by Swiss drugmaker Novartis AG, was approved in 2003.
According to Sun, Gleevec has about $2.5 billion in annual sales in the U.S. It currently has a U.S. list price of about $10,000 per month for the more-common 400-milligram daily dosage.
