🇺🇸 Ensacove in United States

FDA authorised Ensacove on 18 December 2024

Marketing authorisations

FDA — authorised 18 December 2024

Application: NDA218171
Marketing authorisation holder: XCOVERY
Local brand name: ENSACOVE
Indication: CAPSULE — ORAL
Status: approved

The FDA approved Ensacove, a new molecular entity, on 18 December 2024. The marketing authorisation was granted to XCOVERY under the standard expedited pathway. Ensacove is indicated for a specific medical use, but the exact indication is not specified in the available data.

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FDA

Marketing authorisation holder: XCOVERY
Status: approved

Ensacove in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Ensacove approved in United States?

Yes. FDA authorised it on 18 December 2024; FDA has authorised it.

Who is the marketing authorisation holder for Ensacove in United States?

XCOVERY holds the US marketing authorisation.