FDA — authorised 30 March 2010
- Marketing authorisation holder: CHEMISCH FBRK KRSSLR
- Status: approved
🇺🇸 Asclera in United States
FDA authorised Asclera on 30 March 2010
Marketing authorisations
FDA — authorised 21 December 2017
- Application: NDA205098
- Marketing authorisation holder: PROVENSIS
- Indication: Labeling
- Status: approved
FDA — authorised 1 March 2018
- Application: NDA021201
- Marketing authorisation holder: CHEMISCH FBRK KRSSLR
- Indication: Labeling
- Status: approved
Asclera in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Asclera approved in United States?
Yes. FDA authorised it on 30 March 2010; FDA authorised it on 21 December 2017; FDA authorised it on 1 March 2018.
Who is the marketing authorisation holder for Asclera in United States?
CHEMISCH FBRK KRSSLR holds the US marketing authorisation.