paliperidone palmitate

FDA Drug Profile — INVEGA SUSTENNA, Erzofri extended-release, INVEGA HAFYERA, INVEGA TRINZA

Drug Details

Generic Name
paliperidone palmitate
Brand Names
INVEGA SUSTENNA, Erzofri extended-release, INVEGA HAFYERA, INVEGA TRINZA
Application Number
NDA022264
Sponsor
Janssen Pharmaceuticals, Inc.
NDC Codes
17
Dosage Forms
INJECTION, INJECTION, SUSPENSION, EXTENDED RELEASE
Routes
INTRAMUSCULAR
Active Ingredients
PALIPERIDONE PALMITATE

Indications and Usage

1 INDICATIONS AND USAGE INVEGA HAFYERA, an every-six-month injection, is indicated for the treatment of schizophrenia in adults after they have been adequately treated with: A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA) for at least four months, or An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA TRINZA) for at least one three-month cycle. INVEGA HAFYERA, an every-six-month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in adults after they have been adequately treated with: A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA) for at least four months or An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA TRINZA) for at least one three-month cycle. ( 1 )