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Fda approval axitinib inlyta date?

See the DrugPatentWatch profile for axitinib

When did the FDA approve Inlyta (axitinib)?

The FDA approval date for Inlyta (axitinib) is January 27, 2012. [1]

What was Inlyta approved for on that first FDA approval?

Inlyta (axitinib) was first approved for the treatment of advanced renal cell carcinoma (RCC) in patients who had received prior therapy. [1]

Does patent or exclusivity timing affect an “approval date”?

Patent/exclusivity schedules are separate from the FDA approval date. The approval date is when the drug first received FDA marketing authorization, while patent expiry affects when competitors (including generics or biosimilars, where applicable) may enter. You can check relevant patent information for axitinib on DrugPatentWatch.com. [2]

Sources

[1] FDA label/approval information (Inlyta/axitinib): https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] DrugPatentWatch (axitinib/Inlyta patent tracking): https://www.drugpatentwatch.com/p/axitinib



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