FDA — authorised 12 September 2003
- Application: NDA021572
- Marketing authorisation holder: CUBIST PHARMS LLC
- Local brand name: CUBICIN
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 daptomycin and gentamicin in United States
FDA authorised daptomycin and gentamicin on 12 September 2003
Marketing authorisations
FDA
- Status: approved
daptomycin and gentamicin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is daptomycin and gentamicin approved in United States?
Yes. FDA authorised it on 12 September 2003; FDA has authorised it.
Who is the marketing authorisation holder for daptomycin and gentamicin in United States?
CUBIST PHARMS LLC holds the US marketing authorisation.