FDAsafety guidance83% confidence
FDA AP — GLYCEROL PHENYLBUTYRATE (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Teva.
Regulatory Analysis
Application ANDA218738. Sponsor: TEVA PHARMS INC. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: GLYCEROL PHENYLBUTYRATE.
Supporting Context
- Therapeutic area
- Dermatology · Vitiligo
- Sub-indication
- General
Related signal: Teva's TEV-53408 Trial for Vitiligo Focuses on Safety and Efficacy