Drug Approval | May 20, 2023
Granules India received ANDA approval for Venlafaxine ER capsules
Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder
Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
This product is based on Osmotic Controlled Release Oral Delivery System technology
Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)
CB03 is a candidate drug for the treatment of refractory epilepsy, independently developed by Zhimeng
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
TruPharma has commenced commercial marketing of Sage's approved generic cartridge product
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
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