FDA — authorised 22 March 1950
- Marketing authorisation holder: BAXTER HLTHCARE
- Status: approved
🇺🇸 Wydase in United States
FDA authorised Wydase on 22 March 1950
Marketing authorisations
FDA — authorised 5 May 2004
- Application: BLA021640
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 26 October 2004
- Application: BLA021665
- Marketing authorisation holder: AMPHASTAR PHARM
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA — authorised 28 February 2019
- Application: BLA761106
- Marketing authorisation holder: GENENTECH INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 10 June 2021
- Application: BLA761064
- Marketing authorisation holder: GENENTECH INC
- Indication: Labeling
- Status: approved
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 Wydase, 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 was submitted under the standard expedited pathway.
Wydase 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 Wydase approved in United States?
Yes. FDA authorised it on 22 March 1950; FDA authorised it on 5 May 2004; FDA authorised it on 26 October 2004.
Who is the marketing authorisation holder for Wydase in United States?
BAXTER HLTHCARE holds the US marketing authorisation.