FDA — authorised 24 July 2023
- Application: ANDA205182
- Marketing authorisation holder: DR REDDYS
- Local brand name: PLERIXAFOR
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Mozobil in United States
FDA authorised Mozobil on 24 July 2023
Marketing authorisations
FDA — authorised 24 July 2023
- Application: ANDA215334
- Marketing authorisation holder: AMNEAL
- Local brand name: PLERIXAFOR
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 24 July 2023
- Application: ANDA211901
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 24 July 2023
- Application: ANDA215698
- Marketing authorisation holder: MEITHEAL
- Local brand name: PLERIXAFOR
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 24 July 2023
- Application: ANDA205197
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: PLERIXAFOR
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 26 July 2023
- Application: ANDA208980
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: PLERIXAFOR
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
The FDA approved Mozobil for use in the United States on 30 January 2024. The approval was granted to ZYDUS PHARMS through a standard expedited pathway. Mozobil is a drug used in the labelling of the product.
FDA — authorised 3 May 2024
- Application: ANDA206644
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 26 March 2025
- Application: ANDA213672
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
The US FDA approved Mozobil, a drug product, for its approved labeling on 26 March 2025. The marketing authorization holder is EUGIA Pharma. The application was submitted under the standard expedited pathway.
FDA — authorised 16 June 2025
- Application: ANDA217560
- Marketing authorisation holder: HETERO LABS LTD VI
- Status: approved
Mozobil 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 Mozobil approved in United States?
Yes. FDA authorised it on 24 July 2023; FDA authorised it on 24 July 2023; FDA authorised it on 24 July 2023.
Who is the marketing authorisation holder for Mozobil in United States?
DR REDDYS holds the US marketing authorisation.