FDA — authorised 28 September 2006
- Application: NDA050786
- Marketing authorisation holder: LABS JUVISE
- Local brand name: PYLERA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Pylera in United States
FDA authorised Pylera on 28 September 2006
Marketing authorisations
FDA — authorised 6 March 2023
- Application: ANDA205770
- Marketing authorisation holder: PH HEALTH
- Status: approved
FDA — authorised 3 July 2023
- Application: ANDA217511
- Marketing authorisation holder: INGENUS PHARMS LLC
- Status: approved
Pylera 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 Pylera approved in United States?
Yes. FDA authorised it on 28 September 2006; FDA authorised it on 6 March 2023; FDA authorised it on 3 July 2023.
Who is the marketing authorisation holder for Pylera in United States?
LABS JUVISE holds the US marketing authorisation.