CLINICAL & PIPELINE·Drug Approval
FDA Approves CARBAGLU Labeling Update for Recordati Rare Diseases' Orphan Drug
Recordati Rare Diseases secured FDA approval for a supplemental labeling update for its orphan drug, CARBAGLU (carglumic acid), on January 19, 2024. This standard review approval, following earlier efficacy expansions, signals refined prescribing information. For procurement, regulatory, and supply chain leaders, this reinforces CARBAGLU's market position, necessitating vigilance on updated compliance protocols and patient access strategies for this critical rare disease therapy.
90-Day Activity