🇺🇸 Leqselvi in United States

FDA authorised Leqselvi on 25 July 2024

Marketing authorisations

FDA — authorised 25 July 2024

Application: NDA217900
Marketing authorisation holder: SUN PHARM INDS INC
Local brand name: LEQSELVI
Indication: TABLET — ORAL
Status: approved

The FDA approved Leqselvi, a new molecular entity, for marketing in the United States. The approval was granted to SUN PHARM INDS INC on 2024-07-25, following a standard expedited pathway. The exact local brand name for Leqselvi is not reported.

Read official source →

FDA

Marketing authorisation holder: SUN PHARM INDS INC
Status: approved

Leqselvi in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Leqselvi approved in United States?

Yes. FDA authorised it on 25 July 2024; FDA has authorised it.

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

SUN PHARM INDS INC holds the US marketing authorisation.