FDA — authorised 26 February 2004
- Application: BLA125085
- Marketing authorisation holder: GENENTECH
- Local brand name: AVASTIN
- Indication: VIAL — INTRAVENOUS
- Status: approved
🇺🇸 Avastin in United States
FDA authorised Avastin on 26 February 2004
Marketing authorisations
FDA — authorised 13 April 2022
- Application: BLA761231
- Marketing authorisation holder: AMNEAL PHARMS LLC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 27 September 2022
- Application: BLA761268
- Marketing authorisation holder: CELLTRION
- Status: approved
FDA — authorised 6 December 2023
- Application: BLA761198
- Marketing authorisation holder: BIO-THERA SOLUTIONS LTD
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 9 April 2025
- Application: BLA761175
- Marketing authorisation holder: BIOCON BIOLOGICS INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
BIOCON BIOLOGICS INC received marketing authorisation from the FDA for Avastin on 2025-04-09. This approval was granted under the Type 5 indication, which covers new formulations or new manufacturers. The application number for this approval is BLA761175.
Avastin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Avastin approved in United States?
Yes. FDA authorised it on 26 February 2004; FDA authorised it on 13 April 2022; FDA authorised it on 27 September 2022.
Who is the marketing authorisation holder for Avastin in United States?
GENENTECH holds the US marketing authorisation.