FDA — authorised 13 May 2003
- Application: NDA021602
- Marketing authorisation holder: TAKEDA PHARMS USA
- Status: supplemented
🇺🇸 Velcade in United States
FDA authorised Velcade on 13 May 2003
Marketing authorisations
FDA — authorised 2 May 2022
- Application: ANDA209659
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 2 May 2022
- Application: ANDA212825
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 2 May 2022
- Application: ANDA205533
- Marketing authorisation holder: APOTEX
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 2 May 2022
- Application: ANDA208392
- Marketing authorisation holder: PHARMASCIENCE INC
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 26 July 2022
- Application: ANDA203654
- Marketing authorisation holder: CAPLIN ONE LABS
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 26 July 2022
- Application: ANDA209622
- Marketing authorisation holder: MSN
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 26 July 2022
- Application: ANDA202963
- Marketing authorisation holder: DR REDDYS
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 26 July 2022
- Application: ANDA204405
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 27 July 2022
- Application: NDA215331
- Marketing authorisation holder: MAIA PHARMS INC
- Local brand name: BORTEZOMIB
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 31 October 2022
- Application: ANDA205160
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 3 May 2024
- Application: ANDA212204
- Marketing authorisation holder: HETERO LABS LTD VI
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 26 August 2024
- Application: NDA212782
- Marketing authorisation holder: SHILPA
- Local brand name: BORTEZOMIB
- Indication: SOLUTION — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 2 June 2025
- Application: ANDA218688
- Marketing authorisation holder: VILIN BIO MED
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 17 December 2025
- Application: ANDA216528
- Marketing authorisation holder: SHUANGCHENG
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 6 January 2026
- Application: ANDA219167
- Marketing authorisation holder: GLAND
- Local brand name: BORTEZOMIB
- Indication: POWDER — INTRAVENOUS, SUBCUTANEOUS
- Status: approved
The FDA approved BORTEZOMIB (Velcade), a powder for intravenous and subcutaneous administration, on 2026-01-06. This approval was granted to GLAND under the standard expedited pathway. The approved indication for BORTEZOMIB (Velcade) is not specified in the provided information.
FDA
- Application: NDA208645
- Marketing authorisation holder: ACTAVIS LLC
- Local brand name: BORTEZOMIB
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Velcade 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 Velcade approved in United States?
Yes. FDA authorised it on 13 May 2003; FDA authorised it on 2 May 2022; FDA authorised it on 2 May 2022.
Who is the marketing authorisation holder for Velcade in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.