FDA — authorised 23 December 1996
- Application: NDA020665
- Marketing authorisation holder: NOVARTIS
- Local brand name: DIOVAN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Valsartin in United States
FDA authorised Valsartin on 23 December 1996 · 42 US adverse-event reports
Marketing authorisations
FDA — authorised 18 July 2001
- Application: NDA021283
- Marketing authorisation holder: NOVARTIS
- Local brand name: DIOVAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 27 March 2025 – 27 March 2026
- Total reports: 42
Most-reported reactions
- Constipation — 6 reports (14.29%)
- Dyspnoea — 6 reports (14.29%)
- Pruritus — 5 reports (11.9%)
- Drug Ineffective — 4 reports (9.52%)
- Feeling Abnormal — 4 reports (9.52%)
- Pain — 4 reports (9.52%)
- Tremor — 4 reports (9.52%)
- Dehydration — 3 reports (7.14%)
- Dizziness — 3 reports (7.14%)
- Malaise — 3 reports (7.14%)
Other Other approved in United States
Frequently asked questions
Is Valsartin approved in United States?
Yes. FDA authorised it on 23 December 1996; FDA authorised it on 18 July 2001; FDA has authorised it.
Who is the marketing authorisation holder for Valsartin in United States?
NOVARTIS holds the US marketing authorisation.