FDA — authorised 6 October 2000
- Application: NDA021192
- Marketing authorisation holder: SANDOZ
- Status: supplemented
🇺🇸 FLUVASTATIN SODIUM in United States
FDA authorised FLUVASTATIN SODIUM on 6 October 2000 · 941 US adverse-event reports
Marketing authorisations
FDA — authorised 11 April 2012
- Application: ANDA090595
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: FLUVASTATIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 June 2012
- Application: ANDA078407
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: FLUVASTATIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 September 2015
- Application: ANDA202458
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: FLUVASTATIN SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 January 2016
- Application: ANDA079011
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: FLUVASTATIN SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 April 2021
- Application: ANDA209397
- Marketing authorisation holder: BEIJING
- Local brand name: FLUVASTATIN SODIUM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA078872
- Marketing authorisation holder: PAR PHARM
- Local brand name: FLUVASTATIN SODIUM
- Indication: TABLET, EXTENDED RELEASE — 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: 20 April 2025 – 20 April 2026
- Total reports: 941
Most-reported reactions
- Myalgia — 117 reports (12.43%)
- Nausea — 106 reports (11.26%)
- Dizziness — 104 reports (11.05%)
- Diarrhoea — 97 reports (10.31%)
- Fatigue — 90 reports (9.56%)
- Dyspnoea — 89 reports (9.46%)
- Pruritus — 89 reports (9.46%)
- Pyrexia — 85 reports (9.03%)
- Abdominal Pain — 82 reports (8.71%)
- Fall — 82 reports (8.71%)
FLUVASTATIN SODIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is FLUVASTATIN SODIUM approved in United States?
Yes. FDA authorised it on 6 October 2000; FDA authorised it on 11 April 2012; FDA authorised it on 12 June 2012.
Who is the marketing authorisation holder for FLUVASTATIN SODIUM in United States?
SANDOZ holds the US marketing authorisation.