FDA approves Teva's Weltruza, an extended release injectable olanzapine
The agency cleared the new application on October 8, 2026, covering three dosage strengths for the antipsychotic formulation.
The FDA approved Teva Neuroscience's new drug application for Weltruza on October 8, 2026, according to the agency's Drugs@FDA database. The record lists the submission status as AP, with a submission status date of 2026-10-08.1
Weltruza is formulated as an injectable suspension with extended release properties. The approved application covers three products, all listing olanzapine as the active ingredient, in strengths of 531MG, 318MG, and 425MG.1
This is the original application for the product. The filing is classified as submission number 1, an ORIG submission, under submission class "Type 5 - New Formulation or New Manufacturer."1 The FDA designated the review as standard priority rather than priority review, per the same record.
Teva Neuroscience Inc. is listed as the sponsor of the application. The FDA's approval letter for the application is dated October 9, 2026, filed under application number NDA219007.1
No additional details on labeling, indicated use, or post-marketing requirements are included in the available FDA record as of the story date.
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