FDA tentatively approves a generic for CML wonder-drug Gleevec

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The US FDA has given tentative approval to India's Sun Pharmaceutical Industries for an abbreviated new drug application for generic Gleevec (imatinib mesilate) tablets. When Gleevec was introduced in 2001 for the treatment of chronic myleoid leukemia (CML), it was hailed as nothing short of a miracle drug and a magic bullet, and eight years later the medication has lost none of that shine.

However, despite being one of cancer's most remarkable success stories, the Swiss manufacturer Novarits has held tightly to the patent, and a full regimen of the medication costs an astonishing $32,000.

The FDA's tentative approval, coupled with India's unique patent laws, mean that a much more affordable generic version of the medication could be made available in the US some time next year.

By Ross Bonander

Therapeutics Daily
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