FDA — authorised 30 December 1988
- Marketing authorisation holder: BAXTER HLTHCARE
- Status: approved
🇺🇸 Mesnex in United States
FDA authorised Mesnex on 30 December 1988
Marketing authorisations
FDA — authorised 30 December 1988
- Application: NDA019884
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: MESNEX
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 26 April 2001
- Application: ANDA075811
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: MESNA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 April 2001
- Application: ANDA075764
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: MESNA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 21 March 2002
- Application: NDA020855
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: MESNEX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2004
- Application: ANDA075739
- Marketing authorisation holder: HIKMA
- Local brand name: MESNA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
The FDA approved Mesnex, a drug product, for labeling indication on July 17, 2024. The marketing authorization holder is HIKMA. The approval was granted under the standard expedited pathway.
FDA — authorised 13 April 2010
- Application: ANDA090913
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: MESNA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 8 March 2012
- Application: ANDA076488
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: MESNA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 18 July 2014
- Application: ANDA203364
- Marketing authorisation holder: RISING
- Local brand name: MESNA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 6 September 2019
- Application: ANDA206992
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
FDA — authorised 13 January 2025
- Application: ANDA218871
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: MESNA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2026
- Application: ANDA220518
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: MESNA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Mesnex 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 Mesnex approved in United States?
Yes. FDA authorised it on 30 December 1988; FDA authorised it on 30 December 1988; FDA authorised it on 26 April 2001.
Who is the marketing authorisation holder for Mesnex in United States?
BAXTER HLTHCARE holds the US marketing authorisation.