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11/02/2024 03:22:22 am

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FDA Approves First Generic for Gleevec Anti Cancer Pill

FDA's Generic Gleevec Approved

(Photo : gettyimages.com) US drug regulators have approved the first generic Gleevec for cancer treatment.

The United States Food and Drug Administration has approved the first generic version of Gleevec - one of the first very effective, but high valued cancer drugs, costing about $10,000 monthly.

The New York Times reported that Indian drugmaker Sun Pharmaceutical Industries Ltd. was granted subsidiary by the FDA securing the approval to sell generic Gleevec in 100-milligram and 400-milligram pills for the treatment of chronic myeloid leukemia.

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Gleevec is known as imatinib mesylate. It is developed and marketed by Novartis AG, a Swiss drugmaker, and was officially approved in 2003. It was rapidly hailed as a near-cure medication for chronic myeloid leukemia.

The said medication was also supported to combat acute lymphoblastic leukemia and several other types of cancer ailments in adults and children. In some countries, it is known as Glivec.

The more common 400-milligram daily dosage of Gleevec currently has a US list price of about $10,000. It is Novartis top-selling drug, with year 2014 worldwide sales of $4.75 Billion, with the United States contributing $2.5 billion from that global sales figure.

Novartis, the world's leader in cancer medicines and the biggest drug maker by revenue, hopes to limit the market share of U.S. patients who directly defect to generic Gleevec.

According to a Medical Express report, Novartis will be employing a common strategy of brand-name drugmakers whose blockbusters are going off patent, The pharmaceutical giant is offering private insurance discount cards that set their monthly copayment at $10, with the company covering up to $30,000 a year of the pharmacy bill.

 Insurance companies will have to shoulder the remainder. Cash-paying patient or insured individuals under government health programs cannot avail Novartis program.

Beginning February 1, 2016, the Mumbai-based Sun Pharmaceutical, a generic medicine top maker, will start marketing the once-a-day pill in the United States, the company stated on Friday. Sun has a six month permit to sell generic Gleevec with its secured exclusive rights.

The FDA can approve other drugmakers' generic version after the six months duration. From then, prices of this cancer drug should start dropping. 

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