🇺🇸 PRAVASTATIN in United States

FDA authorised PRAVASTATIN on 24 April 2006 · 37,934 US adverse-event reports

Marketing authorisations

FDA — authorised 24 April 2006

  • Application: ANDA076056
  • Marketing authorisation holder: AUROBINDO PHARMA USA
  • Status: supplemented

FDA — authorised 23 October 2006

  • Application: ANDA076341
  • Marketing authorisation holder: APOTEX
  • Status: supplemented

FDA — authorised 23 October 2006

  • Application: ANDA076714
  • Marketing authorisation holder: DR REDDYS LABS INC
  • Status: supplemented

FDA — authorised 15 January 2008

  • Application: ANDA077793
  • Marketing authorisation holder: AUROBINDO PHARMA USA
  • Status: supplemented

FDA — authorised 13 April 2018

  • Application: ANDA209869
  • Marketing authorisation holder: BIOCON PHARMA
  • 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 — 5,193 reports (13.69%)
  2. Diarrhoea — 4,417 reports (11.64%)
  3. Nausea — 4,257 reports (11.22%)
  4. Drug Ineffective — 4,073 reports (10.74%)
  5. Dyspnoea — 3,974 reports (10.48%)
  6. Dizziness — 3,333 reports (8.79%)
  7. Headache — 3,318 reports (8.75%)
  8. Pain — 3,258 reports (8.59%)
  9. Fall — 3,108 reports (8.19%)
  10. Asthenia — 3,003 reports (7.92%)

Source database →

PRAVASTATIN 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 PRAVASTATIN approved in United States?

Yes. FDA authorised it on 24 April 2006; FDA authorised it on 23 October 2006; FDA authorised it on 23 October 2006.

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

AUROBINDO PHARMA USA holds the US marketing authorisation.