FDA — authorised 12 September 2003
- Marketing authorisation holder: CUBIST
- Status: approved
🇺🇸 Cubicin in United States
FDA authorised Cubicin on 12 September 2003
Marketing authorisations
FDA — authorised 21 April 2021
- Application: ANDA212250
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Status: approved
FDA — authorised 16 May 2023
- Application: ANDA206077
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 21 November 2024
- Application: NDA217630
- Marketing authorisation holder: MAIA PHARMS INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Cubicin, a new formulation or new manufacturer, on 21 November 2024. The marketing authorisation holder is MAIA PHARMS INC. This approval was granted under the standard expedited pathway. Cubicin is a drug with an approved indication, but the specific indication is not reported in the available data.
FDA — authorised 30 April 2025
- Application: NDA208385
- Marketing authorisation holder: SAGENT PHARMS INC
- Indication: Labeling
- Status: approved
SAGENT PHARMS INC received marketing authorisation from the FDA for Cubicin on 2025-04-30. Cubicin is a medication used for its approved indication, as stated in the labelling. The marketing authorisation was granted through a standard expedited pathway.
FDA — authorised 30 January 2026
- Application: ANDA213786
- Marketing authorisation holder: MEITHEAL
- Indication: Labeling
- Status: approved
The FDA approved Cubicin, a drug product, for its approved labeling on January 30, 2026. This approval was granted to MEITHEAL, the marketing authorisation holder, through a standard expedited pathway. Cubicin is a drug product with an approved indication, but the specific indication and local brand name are not reported.
Cubicin 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 Cubicin approved in United States?
Yes. FDA authorised it on 12 September 2003; FDA authorised it on 21 April 2021; FDA authorised it on 16 May 2023.
Who is the marketing authorisation holder for Cubicin in United States?
CUBIST holds the US marketing authorisation.