FDAsafety guidance83% confidence
FDA AP — POMALIDOMIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Teva.
Regulatory Analysis
Application ANDA209956. Sponsor: TEVA PHARMS USA. Submission status: AP. Submission type: SUPPL. Active ingredients: POMALIDOMIDE.
Supporting Context
- Therapeutic area
- Dermatology · Vitiligo
- Sub-indication
- General
Related signal: Teva's TEV-53408 Trial for Vitiligo Focuses on Safety and Efficacy