FDA — authorised 31 December 2012
- Marketing authorisation holder: SALIX PHARMS
- Status: approved
🇺🇸 Mytesi in United States
FDA authorised Mytesi on 31 December 2012
Marketing authorisations
FDA — authorised 31 December 2012
- Application: NDA202292
- Marketing authorisation holder: NAPO PHARMS INC
- Local brand name: MYTESI
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
Mytesi 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 Mytesi approved in United States?
Yes. FDA authorised it on 31 December 2012; FDA authorised it on 31 December 2012.
Who is the marketing authorisation holder for Mytesi in United States?
SALIX PHARMS holds the US marketing authorisation.