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FDA
Food and Drug Administration
- Apotex Corp. announced the launch of nilotinib capsules, the first generic version of Tasigna® in the United States, with 180 days of market exclusivity. - The kinase inhibitor is indicated for treating Philadelphia chromosome positive chronic myeloid leukemia in adults and children aged 1 year and older. - The generic launch aims to improve patient access to this critical leukemia treatment by providing a more affordable alternative to the brand-name medication. - Nilotinib demonstrates higher efficacy compared with other available treatments for patients with resistance or intolerance to prior therapy.