🇺🇸 Veregen in United States

FDA authorised Veregen on 31 October 2006 · 34 US adverse-event reports

Marketing authorisations

FDA — authorised 31 October 2006

  • Application: NDA021902
  • Marketing authorisation holder: ANI PHARMS
  • 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. Cellulitis — 6 reports (17.65%)
  2. Application Site Pain — 5 reports (14.71%)
  3. Drug Ineffective — 5 reports (14.71%)
  4. Application Site Erythema — 3 reports (8.82%)
  5. Erythema — 3 reports (8.82%)
  6. Off Label Use — 3 reports (8.82%)
  7. Product Use Issue — 3 reports (8.82%)
  8. Application Site Discharge — 2 reports (5.88%)
  9. Application Site Pruritus — 2 reports (5.88%)
  10. Application Site Ulcer — 2 reports (5.88%)

Source database →

Veregen in other countries

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

Other Other approved in United States

Frequently asked questions

Is Veregen approved in United States?

Yes. FDA authorised it on 31 October 2006; FDA has authorised it.

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

ANI PHARMS holds the US marketing authorisation.