FDA — authorised 15 June 2005
- Marketing authorisation holder: PF PRISM CV
- Status: approved
🇺🇸 Tygacil in United States
FDA authorised Tygacil on 15 June 2005
Marketing authorisations
FDA — authorised 15 June 2005
- Application: NDA021821
- Marketing authorisation holder: PF PRISM CV
- Local brand name: TYGACIL
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 29 September 2017
- Application: ANDA091620
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 12 May 2021
- Application: NDA211158
- Marketing authorisation holder: AMNEAL
- Indication: Labeling
- Status: approved
FDA — authorised 13 May 2021
- Application: ANDA214020
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 24 January 2022
- Application: ANDA206335
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
Tygacil 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 Tygacil approved in United States?
Yes. FDA authorised it on 15 June 2005; FDA authorised it on 15 June 2005; FDA authorised it on 29 September 2017.
Who is the marketing authorisation holder for Tygacil in United States?
PF PRISM CV holds the US marketing authorisation.