Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets
Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder
Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder
The researchers removed a chemical group commonly used in previous NK1R drugs and replaced it with a novel molecular scaffold
Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
Acquisition expands AbbVie's psychiatry pipeline with the addition of a next-generation psychedelic compound currently in Phase 2 development for the treatment of major depressive disorder
Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder
This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis
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