FDA — authorised 29 January 2015
- Application: NDA205395
- Marketing authorisation holder: JANSSEN PRODS
- Local brand name: PREZCOBIX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Prezcobix in United States
FDA authorised Prezcobix on 29 January 2015 · 2,707 US adverse-event reports
Marketing authorisations
FDA — authorised 27 February 2026
- Application: NDA220092
- Marketing authorisation holder: JANSSEN PRODS
- Local brand name: PREZCOBIX
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
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.
- Window: 28 March 2025 – 28 March 2026
- Total reports: 2,707
Most-reported reactions
- Pain — 441 reports (16.29%)
- Emotional Distress — 425 reports (15.7%)
- Anxiety — 403 reports (14.89%)
- Anhedonia — 376 reports (13.89%)
- Chronic Kidney Disease — 256 reports (9.46%)
- Osteoporosis — 181 reports (6.69%)
- Bone Density Decreased — 170 reports (6.28%)
- Renal Failure — 170 reports (6.28%)
- Depression — 147 reports (5.43%)
- Economic Problem — 138 reports (5.1%)
Other Other approved in United States
Frequently asked questions
Is Prezcobix approved in United States?
Yes. FDA authorised it on 29 January 2015; FDA authorised it on 27 February 2026; FDA has authorised it.
Who is the marketing authorisation holder for Prezcobix in United States?
JANSSEN PRODS holds the US marketing authorisation.