FDA — authorised 9 February 2021
- Application: ANDA209564
- Marketing authorisation holder: MYLAN
- Local brand name: LINACLOTIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 ASP0456 in United States
FDA authorised ASP0456 on 9 February 2021
Marketing authorisations
FDA
- Application: ANDA211255
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: LINACLOTIDE
- Indication: CAPSULE — ORAL
- Status: approved
ASP0456 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is ASP0456 approved in United States?
Yes. FDA authorised it on 9 February 2021; FDA has authorised it.
Who is the marketing authorisation holder for ASP0456 in United States?
MYLAN holds the US marketing authorisation.