🇺🇸 Pliaglis in United States

FDA authorised Pliaglis on 29 June 2006 · 64 US adverse-event reports

Marketing authorisations

FDA — authorised 29 June 2006

  • Application: NDA021717
  • Marketing authorisation holder: CRESCITA THERAP
  • Status: supplemented

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. Erythema — 22 reports (34.38%)
  2. Swelling Face — 9 reports (14.06%)
  3. Pruritus — 8 reports (12.5%)
  4. Skin Burning Sensation — 5 reports (7.81%)
  5. Eye Pain — 4 reports (6.25%)
  6. Nausea — 4 reports (6.25%)
  7. Angioedema — 3 reports (4.69%)
  8. Anxiety — 3 reports (4.69%)
  9. Blister — 3 reports (4.69%)
  10. Dizziness — 3 reports (4.69%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Pliaglis approved in United States?

Yes. FDA authorised it on 29 June 2006; FDA has authorised it.

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

CRESCITA THERAP holds the US marketing authorisation.