Prolia approval date?

What was Prolia’s approval date?

Prolia (denosumab) received regulatory approval first in the European Union (as “Prolia”) on 26 May 2010.[1]

When was Prolia approved in the United States?

The U.S. approval (for Prolia) followed later; the FDA approval date was June 1, 2010.[2]

Why do approval dates differ by country?

Approval dates vary because each regulator (e.g., FDA vs. EMA) reviews and grants authorization on its own timeline, based on submission timing and review schedules.

Sources

1. https://www.ema.europa.eu/en/medicines/human/EPAR/prolia
   
2. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125320