FDA — authorised 19 May 2009
- Marketing authorisation holder: OTSUKA AMERICA PHARM
- Status: approved
🇺🇸 Samsca in United States
FDA authorised Samsca on 19 May 2009
Marketing authorisations
FDA — authorised 19 May 2020
- Application: ANDA211891
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 15 February 2022
- Application: ANDA206119
- Marketing authorisation holder: PH HEALTH
- Status: approved
FDA — authorised 6 September 2022
- Application: ANDA207605
- Marketing authorisation holder: APOTEX
- Status: approved
FDA — authorised 21 June 2023
- Application: ANDA216949
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 23 April 2025
- Application: ANDA216063
- Marketing authorisation holder: LUPIN LTD
- Status: approved
Samsca 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 Samsca approved in United States?
Yes. FDA authorised it on 19 May 2009; FDA authorised it on 19 May 2020; FDA authorised it on 15 February 2022.
Who is the marketing authorisation holder for Samsca in United States?
OTSUKA AMERICA PHARM holds the US marketing authorisation.