Friday, July 10, 2026

Drug profile · INN

daratumumab and hyaluronidase-fihj

daratumumab and hyaluronidase-fihj (DARZALEX FASPRO) is an FDA-listed pharmaceutical active ingredient. Route of administration: injection. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — daratumumab and hyaluronidase-fihj
US status
approved
Class
Route
INJECTION
Patents
0
Programs
3
Data quality
0.84

Quick answer

daratumumab and hyaluronidase-fihj (DARZALEX FASPRO) is an FDA-listed pharmaceutical active ingredient. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN daratumumab and hyaluronidase-fihj
Brand DARZALEX FASPRO
Route INJECTION
Formulation INJECTABLE

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Dara SC Phase 3 · Janssen Cilag International · Multiple Myeloma
  2. First-in-human (FIH) Study of DS-1471a in Subjects with Advanced Solid Tumors Phase 1 · Daiichi Sankyo US · Advanced Solid Tumors
  3. GCT3018-01 Phase 1 · Genmab · Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk

Frequently asked questions

What is daratumumab and hyaluronidase-fihj?

daratumumab and hyaluronidase-fihj (DARZALEX FASPRO) is an FDA-listed pharmaceutical active ingredient. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for daratumumab and hyaluronidase-fihj?

DARZALEX FASPRO is a marketed brand name for daratumumab and hyaluronidase-fihj. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of daratumumab and hyaluronidase-fihj?

daratumumab and hyaluronidase-fihj has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.