Teva unveils promising SOLARIS resultsfor Olanzapine LAI
No post-injection Delirium/Sedation Syndrome (PDSS) observed through 56 weeks
No post-injection Delirium/Sedation Syndrome (PDSS) observed through 56 weeks
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychotic disorders
Phase 3 data expected in the second half of 2024
Olanzapine Orally Disintegrating Tablets are used to treat certain mental/mood conditions
Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
Teva reported third quarter revenues of $4.5 billion, an increase of 3 per cent year-over-year.
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
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