FDA — authorised 12 November 2021
- Marketing authorisation holder: PHARMA ESSENTIA CORPORATION
- Status: approved
🇺🇸 Besremi in United States
FDA authorised Besremi on 12 November 2021
Marketing authorisations
FDA — authorised 12 November 2021
- Application: BLA761166
- Marketing authorisation holder: PHARMAESSENTIA CORP
- Local brand name: BESREMI
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
Besremi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Besremi approved in United States?
Yes. FDA authorised it on 12 November 2021; FDA authorised it on 12 November 2021.
Who is the marketing authorisation holder for Besremi in United States?
PHARMA ESSENTIA CORPORATION holds the US marketing authorisation.