FDAsafety guidance83% confidence
FDA AP — MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as Novartis.
Regulatory Analysis
Application ANDA210456. Sponsor: APOTEX. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: ASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, DEXPANTHENOL, FOLIC ACID, NIACINAMIDE, PYRIDOXINE, RIBOFLAVIN, THIAMINE, TOCOPHEROL ACETATE, VITAMIN A, VITAMIN K.
Supporting Context
- Therapeutic area
- Nephrology · IgA Nephropathy
- Sub-indication
- Ild
Related signal: Novartis initiates Phase III trial of Atrasentan in pediatric IgAN patients