A newly revealed mechanism by Weizmann Institute of Science of ketamine’s action on potassium channels in neurons may lead to improved therapies for depression
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.
The researchers removed a chemical group commonly used in previous NK1R drugs and replaced it with a novel molecular scaffold
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
There is a significant unmet medical need for antidepressants that are effective, rapid onset of action and to be well tolerated
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
The company plans to advance Ropanicant into double-blind, placebo-controlled Phase-2b clinical study in MDD patients, anticipated to start in early 2025
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
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