paliperidone palmitate

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

Drug Details

Generic Name
paliperidone palmitate
Brand Names
Erzofri extended-release, INVEGA HAFYERA, INVEGA SUSTENNA, INVEGA TRINZA
Application Number
NDA216352
Sponsor
Shandong Luye Pharmaceutical Co., Ltd.
NDC Codes
17
Dosage Forms
INJECTION, INJECTION, SUSPENSION, EXTENDED RELEASE
Routes
INTRAMUSCULAR
Active Ingredients
PALIPERIDONE PALMITATE

Indications and Usage

1 INDICATIONS AND USAGE INVEGA TRINZA (paliperidone palmitate), a 3-month injection, is indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) for at least four months [see Dosage and Administration (2.2) and Clinical Studies (14) ] . INVEGA TRINZA, a 3-month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) for at least four months. ( 1 )