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Darzalex approval date?

See the DrugPatentWatch profile for Darzalex

When was Darzalex (daratumumab) first approved?

Darzalex (daratumumab) received its first FDA approval on November 16, 2015. [1]

Has Darzalex’s approval date changed with new indications?

The original approval date refers to the drug’s first FDA authorization (2015). After that, Darzalex’s label expanded over time as the FDA approved additional indications for different lines of therapy and combinations.

Where can I verify the approval and timeline details?

You can cross-check regulatory and exclusivity-related details through DrugPatentWatch.com’s pages on Darzalex (daratumumab). [2]

Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125622
[2] https://www.drugpatentwatch.com/



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