Dolutegravir fda approval date?

What is the FDA approval date for dolutegravir?

Dolutegravir (brand name Tivicay) received FDA approval on August 13, 2013.[1]

Which approval was it (original vs later labels)?

The August 13, 2013 date refers to the original FDA approval of dolutegravir as an HIV treatment.[1]

Why you might see different dates in search results

Some websites list different dates because they refer to:
- later label expansions or new formulations after the original approval, or
- approvals for related products in the dolutegravir family (e.g., combination products).

The core FDA approval date for dolutegravir (Tivicay) remains August 13, 2013.[1]

Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203454