FDA — authorised 2 December 2005
- Application: BLA021859
- Marketing authorisation holder: HALOZYME THERAP
- Status: supplemented
🇺🇸 Recombinant in United States
FDA authorised Recombinant on 2 December 2005 · 11,497 US adverse-event reports
Marketing authorisations
FDA — authorised 15 January 2021
- Application: BLA761145
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Efficacy
- Status: approved
FDA — authorised 30 June 2021
- Application: BLA761179
- Marketing authorisation holder: JAZZ PHARMS
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 17 October 2025
- Application: BLA761304
- Marketing authorisation holder: ARGENX BV
- Indication: Efficacy
- Status: approved
The FDA approved ARGENX BV's Recombinant on 2025-10-17 under the application number BLA761304. This approval was granted for the drug's efficacy in its approved indication. The marketing authorisation holder is ARGENX BV, and the drug was approved through the standard expedited pathway.
FDA — authorised 17 December 2025
- Application: BLA761433
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved JANSSEN BIOTECH's Recombinant on 17 December 2025. The approval was granted under the Type 5 indication, which covers new formulations or new manufacturers. This approval allows JANSSEN BIOTECH to market and distribute Recombinant in the United States.
FDA — authorised 13 February 2026
- Application: BLA761484
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Recombinant, a product of JANSSEN BIOTECH, on 13 February 2026. This approval was granted under the Type 5 indication, which covers new formulations or new manufacturers. The application number for this approval is BLA761484.
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 11,497
Most-reported reactions
- Off Label Use — 2,236 reports (19.45%)
- Drug Ineffective — 1,275 reports (11.09%)
- Pneumonia — 1,149 reports (9.99%)
- Product Use Issue — 1,096 reports (9.53%)
- Inappropriate Schedule Of Product Administration — 1,077 reports (9.37%)
- Fatigue — 1,035 reports (9%)
- Condition Aggravated — 942 reports (8.19%)
- Headache — 933 reports (8.12%)
- Pyrexia — 921 reports (8.01%)
- Infusion Related Reaction — 833 reports (7.25%)
Recombinant 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 Recombinant approved in United States?
Yes. FDA authorised it on 2 December 2005; FDA authorised it on 15 January 2021; FDA authorised it on 30 June 2021.
Who is the marketing authorisation holder for Recombinant in United States?
HALOZYME THERAP holds the US marketing authorisation.