🇺🇸 OPDIVO QVANTIG in United States

FDA authorised OPDIVO QVANTIG on 27 December 2024

Marketing authorisations

FDA — authorised 27 December 2024

  • Application: BLA761381
  • Marketing authorisation holder: BRISTOL-MYERS SQUIBB
  • Local brand name: OPDIVO QVANTIG
  • Indication: INJECTABLE — SUBCUTANEOUS
  • Status: approved

The FDA approved OPDIVO QVANTIG, developed by Bristol-Myers Squibb, for its approved indication. This approval was granted through the standard expedited pathway. The application number for this approval is BLA761381.

Read official source →

FDA — authorised 27 December 2024

  • Application: BLA761429
  • Marketing authorisation holder: BRISTOL-MYERS SQUIBB
  • Local brand name: OPDIVO QVANTIG
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

OPDIVO QVANTIG in other countries

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

Other Other approved in United States

Frequently asked questions

Is OPDIVO QVANTIG approved in United States?

Yes. FDA authorised it on 27 December 2024; FDA authorised it on 27 December 2024.

Who is the marketing authorisation holder for OPDIVO QVANTIG in United States?

BRISTOL-MYERS SQUIBB holds the US marketing authorisation.