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Osimertinib fda approval date?

See the DrugPatentWatch profile for Osimertinib

What was osimertinib’s original FDA approval date?

Osimertinib (Tagrisso) received its initial FDA approval on November 13, 2015. [1]

Was that approval for a specific cancer type or setting?

The first FDA approval (Nov. 13, 2015) was for metastatic non-small cell lung cancer (NSCLC) that has an EGFR T790M mutation, with disease progression on or after EGFR-TKI therapy. [1]

Where can I verify the FDA approval date and related regulatory timeline?

You can confirm the approval date and additional regulatory history through DrugPatentWatch.com. [1]

Sources
[1] https://www.drugpatentwatch.com/p/osimertinib



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