🇺🇸 ROSUVASTATIN in United States

FDA authorised ROSUVASTATIN on 31 October 2016 · 60,529 US adverse-event reports

Marketing authorisations

FDA — authorised 31 October 2016

  • Application: ANDA207616
  • Marketing authorisation holder: HETERO LABS LTD V
  • Status: supplemented

FDA — authorised 31 October 2016

  • Application: ANDA207752
  • Marketing authorisation holder: BIOCON PHARMA
  • Status: supplemented

FDA — authorised 1 March 2019

  • Application: ANDA206513
  • Marketing authorisation holder: ZHEJIANG JINGXIN
  • Status: approved

FDA — authorised 9 April 2019

  • Application: ANDA207626
  • Marketing authorisation holder: UMEDICA
  • Status: supplemented

FDA — authorised 6 November 2024

  • Application: ANDA207296
  • Marketing authorisation holder: MACLEODS PHARMS LTD
  • 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.

Most-reported reactions

  1. Fatigue — 8,017 reports (13.24%)
  2. Dyspnoea — 7,008 reports (11.58%)
  3. Drug Ineffective — 6,470 reports (10.69%)
  4. Nausea — 6,312 reports (10.43%)
  5. Off Label Use — 6,199 reports (10.24%)
  6. Diarrhoea — 5,999 reports (9.91%)
  7. Pain — 5,848 reports (9.66%)
  8. Headache — 5,193 reports (8.58%)
  9. Arthralgia — 4,900 reports (8.1%)
  10. Dizziness — 4,583 reports (7.57%)

Source database →

ROSUVASTATIN 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 ROSUVASTATIN approved in United States?

Yes. FDA authorised it on 31 October 2016; FDA authorised it on 31 October 2016; FDA authorised it on 1 March 2019.

Who is the marketing authorisation holder for ROSUVASTATIN in United States?

HETERO LABS LTD V holds the US marketing authorisation.