FDA — authorised 29 October 2010
- Marketing authorisation holder: CEREXA
- Status: approved
🇺🇸 Teflaro in United States
FDA authorised Teflaro on 29 October 2010
Marketing authorisations
FDA — authorised 29 October 2010
- Application: NDA200327
- Marketing authorisation holder: ABBVIE
- Local brand name: TEFLARO
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 21 September 2021
- Application: ANDA208075
- Marketing authorisation holder: APOTEX
- Local brand name: CEFTAROLINE FOSAMIL
- Indication: POWDER — INTRAVENOUS
- Status: approved
The FDA granted marketing authorisation to APOTEX for Teflaro on 2024-05-30. This approval was made through a standard expedited pathway. The approved indication for Teflaro is for its labelling, which outlines its intended use.
Teflaro 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 Teflaro approved in United States?
Yes. FDA authorised it on 29 October 2010; FDA authorised it on 29 October 2010; FDA authorised it on 21 September 2021.
Who is the marketing authorisation holder for Teflaro in United States?
CEREXA holds the US marketing authorisation.