FDA — authorised 27 July 2016
- Marketing authorisation holder: SANOFI-AVENTIS US LLC
- Status: approved
🇺🇸 Adlyxin in United States
FDA authorised Adlyxin on 27 July 2016
Marketing authorisations
FDA — authorised 27 July 2016
- Application: BLA208471
- Marketing authorisation holder: SANOFI-AVENTIS US
- Local brand name: ADLYXIN
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 21 November 2016
- Application: BLA208673
- Marketing authorisation holder: SANOFI-AVENTIS US
- Indication: Type 4 - New Combination
- Status: approved
Adlyxin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Adlyxin approved in United States?
Yes. FDA authorised it on 27 July 2016; FDA authorised it on 27 July 2016; FDA authorised it on 21 November 2016.
Who is the marketing authorisation holder for Adlyxin in United States?
SANOFI-AVENTIS US LLC holds the US marketing authorisation.