FDA authorised Sunlenca on 17 July 2024
GILEAD SCIENCES INC received marketing authorisation from the FDA for Sunlenca on 17 July 2024. The application number for this approval is NDA215973. The indication approved for Sunlenca is listed in the labelling.
GILEAD SCIENCES INC received marketing authorization from the FDA for Sunlenca on 2024-07-17. The application number for this approval is NDA215974. The indication approved for Sunlenca is labeling.
Gilead Sciences Inc received marketing authorisation from the FDA for Sunlenca under the application number NDA220020 on 18 June 2025. The approval was granted for a new indication, which is classified as Type 10. This classification refers to a new indication submitted as a distinct New Drug Application (NDA) that is not consolidated with an existing NDA.
The FDA granted marketing authorisation to Gilead Sciences Inc for Sunlenca, a drug product, on June 18, 2025. This approval was based on a standard expedited pathway. The approved indication is a new indication submitted as a distinct New Drug Application (NDA), denoted as Type 10.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 17 July 2024; FDA authorised it on 17 July 2024; FDA authorised it on 18 June 2025.
GILEAD SCIENCES INC holds the US marketing authorisation.