Olanzapine 10mg/vial; IM inj after reconstitution.
Olanzapine 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg; tabs.
Olanzapine 5mg, 10mg, 15mg, 20mg; orally-disintegrating tabs; contains phenylalanine.
Olanzapine extended-release 210mg/vial, 300mg/vial, 405mg/vial; pwd for susp; for IM inj after reconstitution.
Olanzapine, samidorphan; 5mg/10mg, 10mg/10mg, 15mg/10mg, 20mg/10mg; tabs.
Olanzapine, fluoxetine (as HCl); 3mg/25mg, 6mg/25mg, 6mg/50mg, 12mg/50mg; caps.
Drugs in the Pipeline
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 FDA has approved the first generic versions of Lilly's Zyprexa (olanzapine tablets) and Zyprexa Zydis (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder.
Cross-reactivity can also occur with other drugs due to structural similarities.
The approval was based on data from 27 clinical studies, including the phase 3 ENLIGHTEN-1 and ENLIGHTEN-2 studies.