FDAsafety guidance66% confidence
FDA AP — GLYCEROL PHENYLBUTYRATE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Aurobindo Pharma; the same agency is already in play for this signal, so precedent weight is higher.
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
- Metabolic Disorders · Urea Cycle Disorders
- Sub-indication
- General
Related signal: Aurobindo Pharma's Glycerol Phenylbutyrate Application Receives FDA Review