🇺🇸 Praluent in United States

FDA authorised Praluent on 24 July 2015 · 10,606 US adverse-event reports

Marketing authorisations

FDA — authorised 24 July 2015

  • Application: BLA125559
  • Marketing authorisation holder: REGENERON PHARMACEUTICALS
  • Local brand name: PRALUENT
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

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. Myalgia — 1,539 reports (14.51%)
  2. Product Dose Omission — 1,280 reports (12.07%)
  3. Injection Site Pain — 1,220 reports (11.5%)
  4. Muscle Spasms — 1,103 reports (10.4%)
  5. Arthralgia — 1,007 reports (9.49%)
  6. Fatigue — 977 reports (9.21%)
  7. Product Dose Omission Issue — 900 reports (8.49%)
  8. Pain — 898 reports (8.47%)
  9. Pain In Extremity — 884 reports (8.33%)
  10. Injection Site Bruising — 798 reports (7.52%)

Source database →

Praluent in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in United States

Frequently asked questions

Is Praluent approved in United States?

Yes. FDA authorised it on 24 July 2015; FDA has authorised it.

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

REGENERON PHARMACEUTICALS holds the US marketing authorisation.