FDAsafety guidance83% confidence
FDA AP — MULTIPLE VITAMINS INJECTION PEDIATRIC (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Teva.
Regulatory Analysis
Application ANDA210671. 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
- Neurology · Multiple System Atrophy
- Sub-indication
- General
Related signal: Teva's TEV-56286 Trial for Multiple System Atrophy Underway