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Generic Leukemia Drug Has FDA Approval

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Gleevec (imatinib mesylate) 400 milligrams pills. Generic leukemia drug has FDA approval, Gleevec being one of the first drugs in the world to target chronic myeloid leukemia effectively.

Gleevec (imatinib mesylate) 400 milligrams pills. Generic leukemia drug has FDA approval, Gleevec being one of the first drugs in the world to target chronic myeloid leukemia effectively.

Generic leukemia drug has FDA approval, Gleevec being one of the first drugs in the world to target chronic myeloid leukemia effectively.

Gleevec or Glivec as it is known in some countries is also one of the most expensive treatments on offer for chronic myeloid leukemia. A monthly treatment with Gleevec reaches approximately 10,000 dollars. Nonetheless, Gleevec is the first drug that has brought chronic myeloid leukemia from the status of a fatal disease to a disease which can effectively be managed if long-term medication is strictly followed.

Generic leukemia drug has FDA approval. The FDA has granted one of the subsidiaries of the Sun Pharmaceutical Industries Ltd. the right to sell Gleevec (imatinib mesylate) in two forms: 100 milligrams pills and 400 milligrams pills.

As a result, the Indian drugmaker has announced that with February 1st, 2016 it will start selling imatinib mesylate under the name Gleevec on the U.S. market. Gleevec has been approved in 2003 for Novartis AG, the Swiss pharmaceutical company which developed the generic drug.

Ever since its approval in 2003, Gleevec has been hailed as the closest opportunity for a chronic myeloid leukemia cure. In addition to targeting chronic myeloid leukemia, the generic drug has been approved for treating several other cancers in both children and adults, including acute lymphoblastic leukemia.

Gleevec has been the best selling drug for Swiss Novartis AG. In 2014, Gleevec global sales reached a whooping 4.75 billion dollars. The U.S. market amounted to 2.5 billion dollars in sales. The most common form of the generic drug sold on the U.S. market is the 400 milligrams pill.

Novartis AG is the largest drug maker by revenue in the world. In addition, the pharmaceutical company is the global leader in providing cancer treatments. Currently, making use of a commonly employed strategy among the largest brand-name pharma companies, Novartis AG offers privately insured patients discount cards, reducing the monthly co-payment to 10 dollars. Insurance companies pay some of the rest, while Novartis AG is responsible for covering approximately 30,000 dollars per year. However, patients who are insured via government programs aren’t included in the scheme.

As the generic leukemia drug has FDA approval, Sun Pharmaceutical Industries Ltd. will exclusively sell Gleevec over a period of six months. Provided the FDA gives its approval for other generic versions, it is expected that the monthly treatment cost will drop significantly.

Photo Credits: Wikimedia


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