FDA — authorised 28 October 1996
- Application: NDA019821
- Marketing authorisation holder: STIEFEL LABS INC
- Local brand name: SORIATANE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Soriatane in United States
FDA authorised Soriatane on 28 October 1996
Marketing authorisations
FDA — authorised 4 April 2013
- Application: ANDA202897
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ACITRETIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 April 2013
- Application: ANDA091455
- Marketing authorisation holder: BARR LABS INC
- Local brand name: ACITRETIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 September 2015
- Application: ANDA202148
- Marketing authorisation holder: MYLAN
- Local brand name: ACITRETIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 September 2015
- Application: ANDA203707
- Marketing authorisation holder: MYLAN
- Local brand name: ACITRETIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 December 2015
- Application: ANDA202552
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: ACITRETIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 April 2018
- Application: ANDA204633
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Indication: Labeling
- Status: approved
FDA — authorised 5 August 2024
- Application: ANDA217774
- Marketing authorisation holder: ALEMBIC
- Local brand name: ACITRETIN
- Indication: CAPSULE — ORAL
- Status: approved
Soriatane 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 Soriatane approved in United States?
Yes. FDA authorised it on 28 October 1996; FDA authorised it on 4 April 2013; FDA authorised it on 4 April 2013.
Who is the marketing authorisation holder for Soriatane in United States?
STIEFEL LABS INC holds the US marketing authorisation.