FDA — authorised 25 September 2009
- Application: BLA125261
- Marketing authorisation holder: CENTOCOR ORTHO BIOTECH INC
- Local brand name: STELARA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Stelara in United States
FDA authorised Stelara on 25 September 2009
Marketing authorisations
FDA — authorised 18 October 2024
- Application: BLA761343
- Marketing authorisation holder: ALVOTECH USA INC
- Indication: Labeling
- Status: approved
The FDA approved Stelara for its labelled indication on 18 October 2024. The application was submitted by ALVOTECH USA INC under the standard expedited pathway. The approval was granted based on the BLA761343 application.
FDA — authorised 28 April 2025
- Application: BLA761338
- Marketing authorisation holder: CELLTRION, INC.
- Indication: Labeling
- Status: approved
The FDA approved Stelara, manufactured by CELLTRION, INC., for its approved indication on 28 April 2025. The application number for this approval is BLA761338. This approval was granted through the standard expedited pathway.
FDA — authorised 25 September 2025
- Application: BLA761285
- Marketing authorisation holder: AMGEN INC
- Indication: Labeling
- Status: approved
The FDA approved Stelara, manufactured by Amgen Inc., for its approved labeling on September 25, 2025. This approval was granted through a standard expedited pathway. The application number for this approval is BLA761285.
FDA — authorised 25 September 2025
- Application: BLA761331
- Marketing authorisation holder: AMGEN INC
- Indication: Labeling
- Status: approved
The FDA approved Stelara, manufactured by Amgen Inc., for its approved labeling on September 25, 2025. This approval was granted under the standard expedited pathway. The application number for this approval is BLA761331.
Stelara 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 Stelara approved in United States?
Yes. FDA authorised it on 25 September 2009; FDA authorised it on 18 October 2024; FDA authorised it on 28 April 2025.
Who is the marketing authorisation holder for Stelara in United States?
CENTOCOR ORTHO BIOTECH INC holds the US marketing authorisation.