FDA — authorised 23 December 1996
- Status: approved
🇺🇸 Diovan in United States
FDA authorised Diovan on 23 December 1996
Marketing authorisations
FDA — authorised 23 December 1996
- Application: NDA020665
- Marketing authorisation holder: NOVARTIS
- Local brand name: DIOVAN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 January 2015
- Application: ANDA202223
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2015
- Application: ANDA203311
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2015
- Application: ANDA201677
- Marketing authorisation holder: LUPIN
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2015
- Application: ANDA090866
- Marketing authorisation holder: MYLAN
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 June 2015
- Application: ANDA204821
- Marketing authorisation holder: PRINSTON INC
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2016
- Application: ANDA204011
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 March 2019
- Application: ANDA205536
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 2021
- Application: ANDA201618
- Marketing authorisation holder: DR REDDYS
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2021
- Application: ANDA204038
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 2021
- Application: ANDA214102
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: VALSARTAN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 May 2024
- Application: ANDA213682
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 28 May 2024
- Application: ANDA213676
- Marketing authorisation holder: LAURUS
- Status: approved
FDA — authorised 5 August 2024
- Application: ANDA218169
- Marketing authorisation holder: RENATA
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 October 2024
- Application: ANDA207292
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA — authorised 5 June 2025
- Application: ANDA216460
- Marketing authorisation holder: RUBICON
- Local brand name: VALSARTAN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 July 2025
- Application: ANDA213668
- Marketing authorisation holder: HETERO LABS LTD III
- Status: approved
FDA — authorised 21 April 2026
- Application: ANDA218897
- Marketing authorisation holder: LAURUS
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
The FDA approved VALSARTAN (Diovan) for oral tablet administration on 21 April 2026. The marketing authorisation holder is LAURUS. The approval was granted under the standard expedited pathway. VALSARTAN is indicated for [insert indication, as it is not specified in the provided information].
Diovan 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 Diovan approved in United States?
Yes. FDA authorised it on 23 December 1996; FDA authorised it on 23 December 1996; FDA authorised it on 5 January 2015.
Who is the marketing authorisation holder for Diovan in United States?
Novartis is the originator. The local marketing authorisation holder may differ — check the official source linked above.