🇺🇸 Winrevair in United States

FDA authorised Winrevair on 26 March 2024

Marketing authorisations

FDA — authorised 26 March 2024

Application: BLA761363
Marketing authorisation holder: MERCK SHARP DOHME
Local brand name: WINREVAIR
Indication: INJECTABLE — INJECTION
Status: approved

The FDA granted marketing authorisation to Winrevair, a drug developed by Merck Sharp Dohme, on 25 March 2026. The marketing authorisation was granted under the standard expedited pathway. The approved indication for Winrevair is listed as 'Labeling', but the specific indication is not reported in the available data.

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FDA

Marketing authorisation holder: MERCK SHARP DOHME
Status: approved

Winrevair in other countries

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

Other Cardiovascular approved in United States

Frequently asked questions

Is Winrevair approved in United States?

Yes. FDA authorised it on 26 March 2024; FDA has authorised it.

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

MERCK SHARP DOHME holds the US marketing authorisation.