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approval · primary record

OFATUMUMAB

FDA · BLA · 2026-04-01

AgencyFDA
Submission typeBLA
Action date2026-04-01
BrandKESIMPTA
SponsorNOVARTIS
RouteSUBCUTANEOUS

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:34:33.841Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:OFATUMUMAB:2026-04-01

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OFATUMUMAB — approval | AEaH