FDA — authorised 16 December 2013
- Application: NDA200327
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
🇺🇸 Ceftaroline Fosamil in United States
FDA authorised Ceftaroline Fosamil on 16 December 2013
Marketing authorisations
FDA — authorised 30 May 2024
- Application: ANDA208075
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
The FDA approved Ceftaroline Fosamil for marketing in the United States on 2024-05-30. The approval was granted to APOTEX under application number ANDA208075. Ceftaroline Fosamil is a cephalosporin antibiotic used for the treatment of various bacterial infections.
FDA
- Marketing authorisation holder: ABBVIE
- Status: approved
Ceftaroline Fosamil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Ceftaroline Fosamil approved in United States?
Yes. FDA authorised it on 16 December 2013; FDA authorised it on 30 May 2024; FDA has authorised it.
Who is the marketing authorisation holder for Ceftaroline Fosamil in United States?
ABBVIE holds the US marketing authorisation.