While the CRL did not raise clinical concerns, the Agency noted that certain conditions related to the tablet coating process needed to be resolved.
Your search for olanzapine returned 98 results
The application includes data from the ENLIGHTEN-1 and ENLIGHTEN-2 studies, in which treatment with the combination therapy was compared with placebo or olanzapine monotherapy in patients with schizophrenia.
The review found no statistically significant difference between the two groups regarding adherence and treatment response.
A new article reports on a study comparing the safety and efficacy of olanzapine/fluoxetine combination therapy (OFC) v.s fluoxetine monotherapy in patients with treatment-resistant major depressive disorder (MDD).
For patients receiving highly emetogenic chemotherapy who experience breakthrough chemotherapy-induced nausea and vomiting, treatment with olanzapine (Zyprexa) is significantly better than treatment with metoclopramide.
Olanzapine, samidorphan; 5mg/10mg, 10mg/10mg, 15mg/10mg, 20mg/10mg; tabs.
Olanzapine, fluoxetine (as HCl); 3mg/25mg, 6mg/25mg, 6mg/50mg, 12mg/50mg; caps.
Findings compared with both younger women and similarly aged men
The study authors focused on 4 pharmacologic classes: glucocorticoids, antiretroviral therapies, newer atypical antipsychotics, and immune checkpoint inhibitors.
Lybalvi is an atypical antipsychotic comprised of samidorphan co-formulated with olanzapine in a single bilayer tablet.