Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)
Abbott has recently received the US Food and Drug Administration nod to use its DBS device for treatment-resistant depression
The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023
Vortioxetine is a novel antidepressant with multimodal activity, which is approved to treat Major Depressive Disorder (MDD) in adults
Expands AbbVie's neuroscience portfolio, adding first-in-class modulators of the synaptic vesicle protein 2A, including lead molecule SDI-118 currently in Phase 1b studies
It has a total of 50 ANDA approvals from USFDA
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
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