FDA Gives Chelsea Therapeutics Drug Orphan, Fast-Track Status

摘要

Chelsea Therapeutics' hypotension drug Droxidopa received fast-track and orphan-drug status from the FDA, as well as a special protocol assessment for a Phase III clinical trial. Chelsea is seeking approval for the drug to treat symptomatic neurogenic orthostatic hypotension, a chronic disorder in which a patient has decreased blood pressure when standing, causing light-headedness, dizziness, blurred vision and syncope.