🇺🇸 XaraColl in United States

FDA authorised XaraColl on 28 August 2020 · 28 US adverse-event reports

Marketing authorisation

FDA — authorised 28 August 2020

  • Application: NDA209511
  • Marketing authorisation holder: INNOCOLL PHARMS
  • Local brand name: XARACOLL
  • Indication: IMPLANT — IMPLANTATION
  • Status: approved

Read official source →

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. Bloody Discharge — 5 reports (17.86%)
  2. Post Procedural Haematoma — 5 reports (17.86%)
  3. Procedural Pain — 4 reports (14.29%)
  4. Off Label Use — 3 reports (10.71%)
  5. Seroma — 3 reports (10.71%)
  6. Platelet Dysfunction — 2 reports (7.14%)
  7. Postoperative Wound Infection — 2 reports (7.14%)
  8. Wound Abscess — 2 reports (7.14%)
  9. Incision Site Swelling — 1 report (3.57%)
  10. Inguinal Hernia — 1 report (3.57%)

Source database →

Frequently asked questions

Is XaraColl approved in United States?

Yes. FDA authorised it on 28 August 2020.

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

INNOCOLL PHARMS holds the US marketing authorisation.