FDA — authorised 7 May 1982
- Status: approved
🇺🇸 Accutane in United States
FDA authorised Accutane on 7 May 1982
Marketing authorisations
FDA — authorised 7 May 1982
- Application: NDA018662
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: ACCUTANE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 November 2002
- Application: ANDA075945
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: AMNESTEEM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 December 2002
- Application: ANDA076041
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: SOTRET
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 April 2003
- Application: ANDA076356
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CLARAVIS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 April 2003
- Application: ANDA076135
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CLARAVIS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 June 2003
- Application: ANDA076503
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: SOTRET
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 January 2012
- Application: ANDA076485
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: MYORISAN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 May 2012
- Application: NDA021951
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: ABSORICA
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 March 2013
- Application: ANDA202099
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: ZENATANE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 November 2019
- Application: NDA211913
- Marketing authorisation holder: SUN PHARM
- Local brand name: ABSORICA LD
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 March 2021
- Application: ANDA205063
- Marketing authorisation holder: ACTAVIS LABS FL
- Local brand name: ISOTRETINOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 April 2021
- Application: ANDA213571
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: ISOTRETINOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 August 2023
- Application: ANDA211568
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ISOTRETINOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 January 2024
- Application: ANDA218194
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ISOTRETINOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 May 2025
- Application: ANDA216633
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ISOTRETINOIN
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved Accutane for a Risk Evaluation and Mitigation Strategy (REMS) indication on 2026-02-09. ZYDUS PHARMS is the marketing authorisation holder. The approval was granted under the standard expedited pathway.
FDA — authorised 7 October 2025
- Application: ANDA216097
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: ISOTRETINOIN
- Indication: CAPSULE — ORAL
- Status: approved
Accutane 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 Accutane approved in United States?
Yes. FDA authorised it on 7 May 1982; FDA authorised it on 7 May 1982; FDA authorised it on 8 November 2002.
Who is the marketing authorisation holder for Accutane in United States?
Marketing authorisation holder not available in our data.