FDA Acceptance for Filing of New Drug Application (NDA) for Trientine Tetrahydrochloride (TETA 4HCl) for the treatment of Wilson ’s Disease

NDA supported by positive data from Phase 3 CHELATE clinical trial TETA 4-HCl previously granted Orphan Drug Designation for first-line treatment of Wilson’s Disease Paris, France– 02 September 2021 – Orphalan SA, a...
Source: Drugs.com - New Drug Applications - Category: Drugs & Pharmacology Source Type: news