FDA — authorised 25 January 2013
- Application: ANDA076747
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ROSIGLITAZONE MALEATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ROSIGLITAZONE MALEATE in United States
FDA authorised ROSIGLITAZONE MALEATE on 25 January 2013 · 2,522 US adverse-event reports
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA078825
- Marketing authorisation holder: MYLAN PHARMA
- Local brand name: ROSIGLITAZONE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078658
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: ROSIGLITAZONE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078674
- Marketing authorisation holder: SANDOZ
- Local brand name: ROSIGLITAZONE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078695
- Marketing authorisation holder: ROXANE
- Local brand name: ROSIGLITAZONE MALEATE
- Indication: TABLET — ORAL
- 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: 2,522
Most-reported reactions
- Myocardial Infarction — 711 reports (28.19%)
- Cardiac Failure Congestive — 491 reports (19.47%)
- Death — 409 reports (16.22%)
- Cerebrovascular Accident — 310 reports (12.29%)
- Coronary Artery Disease — 202 reports (8.01%)
- Cardiac Disorder — 106 reports (4.2%)
- Dyspnoea — 95 reports (3.77%)
- Renal Failure — 67 reports (2.66%)
- Atrial Fibrillation — 66 reports (2.62%)
- Hypertension — 65 reports (2.58%)
ROSIGLITAZONE MALEATE 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 ROSIGLITAZONE MALEATE approved in United States?
Yes. FDA authorised it on 25 January 2013; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for ROSIGLITAZONE MALEATE in United States?
ANI PHARMS holds the US marketing authorisation.