FDA c'tee recommends Zyprexa LAI approval
The US Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee has concluded that Zyprexa LAI (olanzapine) is effective and has an acceptable safety profile for the treatment of schizophrenia in adults. The committee added that, provided appropriate information regarding the potential for excessive sedation events is provided, the product is suitable for approval.
Zyprexa LAI, which is made by USA-based drug major Eli Lilly, is a long-acting injectable version of the oral atypical antipsychotic agent Zyprexa, which was originally approved in 1996 (Marketletters passim). The new formulation contains a pamoate salt that is designed to ensure delivery of the drug over a four-week period.
Sedation management plan included in NDA
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