FDAsafety guidance66% confidence
Centaur Pharmaceuticals Private Ltd. - 651080 - 06/05/2023
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
Supporting Context
- Therapeutic area
- Gastroenterology · IBS-D
- Sub-indication
- General
Related signal: Aurobindo Pharma's ANDA213511 for Eluxadoline Receives AP Status