🇺🇸 INVEGA SUSTENNA in United States

FDA authorised INVEGA SUSTENNA on 31 July 2009 · 11,946 US adverse-event reports

Marketing authorisations

FDA — authorised 31 July 2009

  • Application: NDA022264
  • Marketing authorisation holder: JANSSEN PHARMS
  • Local brand name: INVEGA SUSTENNA
  • Indication: SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
  • 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. Off Label Use — 2,308 reports (19.32%)
  2. Drug Ineffective — 1,436 reports (12.02%)
  3. Weight Increased — 1,368 reports (11.45%)
  4. Drug Dose Omission — 1,333 reports (11.16%)
  5. Hospitalisation — 1,191 reports (9.97%)
  6. Gynaecomastia — 1,037 reports (8.68%)
  7. Product Dose Omission Issue — 969 reports (8.11%)
  8. Blood Prolactin Increased — 802 reports (6.71%)
  9. Incorrect Dose Administered — 763 reports (6.39%)
  10. Treatment Noncompliance — 739 reports (6.19%)

Source database →

INVEGA SUSTENNA in other countries

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

Frequently asked questions

Is INVEGA SUSTENNA approved in United States?

Yes. FDA authorised it on 31 July 2009; FDA has authorised it.

Who is the marketing authorisation holder for INVEGA SUSTENNA in United States?

JANSSEN PHARMS holds the US marketing authorisation.