FDA sends warning to Alar over misleading claims about investigational depression drug

The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion sent an untitled warning letter to Alar Pharmaceuticals.

The agency says Alar’s promotional materials for ALA-3000, an investigational ketamine pamoate intended for treatment-resistant depression, contain misleading statements about the drug’s safety and effectiveness.

The notice highlights the FDA’s focus on accurate advertising for drugs that have not yet received approval, and Alar will likely need to revise its claims to comply with regulations.