Olanzapine pamoate
Olanzapine pamoate is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including ZYPREXA Relprevv. Available dosage forms: injection, powder, for suspension, extended release, kit.
Drug Details
- Generic Name
- Olanzapine pamoate
- Brand Names
- ZYPREXA Relprevv
- Application Number
- NDA022173
- Sponsor
- Synergy Health AST, LLC
- NDC Codes
- 6
- Dosage Forms
- INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE, KIT
- Routes
- INTRAMUSCULAR
- Active Ingredients
- OLANZAPINE PAMOATE
Indications and Usage
1 INDICATIONS AND USAGE ZYPREXA RELPREVV is available only through a restricted distribution program [see Warnings and Precautions ( 5.2 )] . ZYPREXA RELPREVV must not be dispensed directly to a patient. For a patient to receive treatment, the prescriber, healthcare setting, patient, and pharmacy must all be enrolled in the ZYPREXA RELPREVV REMS. To enroll, call 1-877-772-9390. ZYPREXA ® RELPREVV™ is a long-acting atypical antipsychotic for intramuscular injection indicated for the treatment of schizophrenia. ( 1.1 ) Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults. ( 14.1 ) 1.1 Schizophrenia ZYPREXA RELPREVV is indicated for the treatment of schizophrenia. Efficacy was established in two clinical trials in patients with schizophrenia: one 8-week trial in adults and one maintenance trial in adults [see Clinical Studies ( 14.1 )] .