🇺🇸 Auvelity in United States

FDA authorised Auvelity on 18 August 2022 · 1,731 US adverse-event reports

Marketing authorisations

FDA — authorised 18 August 2022

  • Application: NDA215430
  • Marketing authorisation holder: AXSOME
  • Local brand name: AUVELITY
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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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. Dizziness — 274 reports (15.83%)
  2. Feeling Abnormal — 230 reports (13.29%)
  3. Anxiety — 185 reports (10.69%)
  4. Drug Ineffective — 176 reports (10.17%)
  5. Inappropriate Schedule Of Product Administration — 175 reports (10.11%)
  6. Off Label Use — 145 reports (8.38%)
  7. Nausea — 143 reports (8.26%)
  8. Fatigue — 140 reports (8.09%)
  9. Depression — 139 reports (8.03%)
  10. Headache — 124 reports (7.16%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Auvelity approved in United States?

Yes. FDA authorised it on 18 August 2022; FDA has authorised it.

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

AXSOME holds the US marketing authorisation.