FDA — authorised 31 July 2009
- Application: NDA022264
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: INVEGA SUSTENNA
- Indication: SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
🇺🇸 Invega Sustenna in United States
FDA authorised Invega Sustenna on 31 July 2009
Marketing authorisations
FDA — authorised 31 July 2009
- Marketing authorisation holder: JANSSEN PHARMS
- Status: approved
FDA — authorised 18 May 2015
- Application: NDA207946
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: INVEGA TRINZA
- Indication: SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
FDA — authorised 22 January 2025
- Application: NDA216352
- Marketing authorisation holder: LUYE INNOMIND PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Invega Sustenna, a medication for the treatment of schizophrenia, on 22 January 2025. The approval was granted to LUYE INNOMIND PHARMA under the standard expedited pathway. Invega Sustenna is a long-acting injectable formulation of paliperidone, an atypical antipsychotic.
FDA
- Application: ANDA210397
- Marketing authorisation holder: PHARMASCIENCE INC
- Local brand name: PALIPERIDONE PALMITATE
- Indication: SUSPENSION — EXTENDED RELEASE
- Status: approved
FDA
- Application: ANDA211995
- Marketing authorisation holder: TOLMAR
- Local brand name: PALIPERIDONE PALMITATE
- Indication: SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
FDA
- Application: ANDA215682
- Marketing authorisation holder: MYLAN PHARMACEUTICALS INC A VIATRIS CO
- Local brand name: PALIPERIDONE PALMITATE
- Indication: INJECTION — SUSPENSION
- Status: approved
Invega Sustenna in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Invega Sustenna approved in United States?
Yes. FDA authorised it on 31 July 2009; FDA authorised it on 31 July 2009; FDA authorised it on 18 May 2015.
Who is the marketing authorisation holder for Invega Sustenna in United States?
JANSSEN PHARMS holds the US marketing authorisation.