JUL 28, 2026 · REGULATORY APPROVAL
FDA approval: Glycerol Phenylbutyrate
U.S. Food and Drug Administration
FDA approval of glycerol phenylbutyrate oral liquid formulation; regulatory action confirms marketability but does not report clinical trial outcomes or comparative efficacy.
Reported
Approval status date2026-07-28
Formulation strength1.1 g/mL
Application typeANDA (Abbreviated New Drug Application)