FDA — authorised 26 November 1985
- Application: NDA050587
- Marketing authorisation holder: MERCK
- Local brand name: PRIMAXIN
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Primaxin in United States
FDA authorised Primaxin on 26 November 1985
Marketing authorisations
FDA — authorised 26 November 1985
- Status: approved
FDA — authorised 8 January 1987
- Application: ANDA062756
- Marketing authorisation holder: MERCK
- Local brand name: PRIMAXIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 December 1990
- Application: NDA050630
- Marketing authorisation holder: MERCK
- Local brand name: PRIMAXIN
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA — authorised 15 April 2015
- Application: ANDA090577
- Marketing authorisation holder: ACS DOBFAR
- Indication: Labeling
- Status: approved
FDA — authorised 4 June 2020
- Application: NDA212819
- Marketing authorisation holder: MSD MERCK CO
- Indication: Efficacy
- Status: approved
FDA — authorised 4 April 2024
- Application: ANDA207594
- Marketing authorisation holder: HQ SPCLT PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Primaxin, a drug product, on 2024-04-04. The marketing authorisation holder is HQ SPCLT PHARMA. The approval was granted under the standard expedited pathway. The indication approved is for labeling.
Primaxin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Primaxin approved in United States?
Yes. FDA authorised it on 26 November 1985; FDA authorised it on 26 November 1985; FDA authorised it on 8 January 1987.
Who is the marketing authorisation holder for Primaxin in United States?
MERCK holds the US marketing authorisation.