FDA — authorised 5 January 2001
- Application: NDA021252
- Marketing authorisation holder: ABBVIE
- Local brand name: CANASA
- Indication: SUPPOSITORY — RECTAL
- Status: approved
🇺🇸 Canasa in United States
FDA authorised Canasa on 5 January 2001
Marketing authorisations
FDA — authorised 17 September 2004
- Application: ANDA076751
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 30 September 2004
- Application: ANDA076841
- Marketing authorisation holder: G AND W LABS INC
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 29 May 2008
- Application: NDA021830
- Marketing authorisation holder: ABBVIE
- Local brand name: ASACOL HD
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 November 2015
- Application: ANDA204354
- Marketing authorisation holder: QUAGEN
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA203286
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 20 November 2018
- Application: ANDA203574
- Marketing authorisation holder: MYLAN
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 19 April 2019
- Application: ANDA207448
- Marketing authorisation holder: RISING
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 21 June 2019
- Application: ANDA208362
- Marketing authorisation holder: AMRING PHARMS
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 12 February 2020
- Application: ANDA208953
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 14 August 2020
- Application: ANDA205654
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: MESALAMINE
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 12 August 2021
- Application: ANDA208954
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 May 2022
- Application: ANDA209970
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 October 2022
- Application: ANDA216967
- Marketing authorisation holder: ALEMBIC
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 March 2023
- Application: ANDA214477
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 May 2023
- Application: ANDA217337
- Marketing authorisation holder: SINOTHERAPEUTICS INC
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 30 May 2023
- Application: ANDA216941
- Marketing authorisation holder: ENCUBE
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 22 August 2024
- Application: ANDA218410
- Marketing authorisation holder: NOVAST LABS
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 August 2024
- Application: ANDA213191
- Marketing authorisation holder: TEVA PHARMS INC
- Local brand name: MESALAMINE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 16 April 2025
- Application: ANDA215269
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- Status: approved
FDA — authorised 10 March 2026
- Application: ANDA219997
- Marketing authorisation holder: DIFGEN PHARMS
- Local brand name: MESALAMINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved Canasa (mesalamine) extended-release capsules for oral use on 10 March 2026. This approval was granted to DIFGEN PHARMS through a standard expedited pathway. Canasa is indicated for the treatment of ulcerative colitis.
FDA — authorised 31 March 2026
- Application: ANDA220016
- Marketing authorisation holder: KLM LABS PVT
- Local brand name: MESALAMINE
- Indication: ENEMA — RECTAL
- Status: approved
The FDA approved Canasa (mesalamine) enema for the treatment of ulcerative proctitis. This approval was granted to KLM Labs PVT under the standard expedited pathway. The approval was based on the application number ANDA220016, which was submitted to the FDA for review.
Other Other approved in United States
Frequently asked questions
Is Canasa approved in United States?
Yes. FDA authorised it on 5 January 2001; FDA authorised it on 17 September 2004; FDA authorised it on 30 September 2004.
Who is the marketing authorisation holder for Canasa in United States?
ABBVIE holds the US marketing authorisation.