FDA — authorised 14 March 1996
- Application: ANDA074513
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
🇺🇸 Vepesid in United States
FDA authorised Vepesid on 14 March 1996
Marketing authorisations
FDA — authorised 20 November 1996
- Application: ANDA074290
- Marketing authorisation holder: HIKMA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 19 November 1999
- Application: ANDA074529
- Marketing authorisation holder: MEITHEAL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 9 November 2016
- Application: NDA020457
- Marketing authorisation holder: CHEPLAPHARM
- Indication: Labeling
- Status: approved
FDA — authorised 13 February 2026
- Application: NDA220200
- Marketing authorisation holder: AVYXA HOLDINGS
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Vepesid, a medication developed by AVYXA HOLDINGS, on 13 February 2026. The approval was granted under the standard expedited pathway for a new dosage form. This approval allows AVYXA HOLDINGS to market Vepesid in the United States for the approved indication.
Vepesid 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 Vepesid approved in United States?
Yes. FDA authorised it on 14 March 1996; FDA authorised it on 20 November 1996; FDA authorised it on 19 November 1999.
Who is the marketing authorisation holder for Vepesid in United States?
ACCORD HLTHCARE holds the US marketing authorisation.