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Osimertinib first fda approval date tagrisso?

See the DrugPatentWatch profile for Osimertinib

When was Tagrisso (osimertinib) first approved by the FDA?

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

Does “first approval date” mean the first FDA approval of any osimertinib indication?

Yes. November 13, 2015 refers to the drug’s initial FDA approval (as opposed to later label expansions for additional stages or mutations). [1]

Related: when did Tagrisso become available for broader use?

Later FDA approvals expanded Tagrisso’s indicated use to additional patient groups and settings beyond the original approval. Those expansions came after the first FDA approval date in 2015. [1]

Sources:
[1] https://www.drugs.com/history/tagrisso.html



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