FDA — authorised 15 December 1995
- Marketing authorisation holder: ABBVIE
- Status: approved
🇺🇸 Nimbex in United States
FDA authorised Nimbex on 15 December 1995
Marketing authorisations
FDA — authorised 15 December 1995
- Application: NDA020551
- Marketing authorisation holder: ABBVIE
- Local brand name: NIMBEX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 May 2020
- Application: ANDA209144
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 26 May 2020
- Application: ANDA209132
- Marketing authorisation holder: SOMERSET
- Indication: Labeling
- Status: approved
FDA — authorised 24 May 2022
- Application: ANDA215516
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 28 June 2022
- Application: ANDA203078
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 8 October 2024
- Application: ANDA203079
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
The FDA approved Nimbex, a generic version of a neuromuscular blocking agent, for marketing in the United States. The approval was granted to HIKMA on 2024-10-08 under the standard expedited pathway. Nimbex is indicated for use in surgical procedures to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery.
Nimbex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Nimbex approved in United States?
Yes. FDA authorised it on 15 December 1995; FDA authorised it on 15 December 1995; FDA authorised it on 8 May 2020.
Who is the marketing authorisation holder for Nimbex in United States?
ABBVIE holds the US marketing authorisation.