FDAsafety guidance66% confidence
FDA AP — OMEPRAZOLE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Marksans Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA207740. Sponsor: DR REDDYS. Submission status: AP. Submission type: SUPPL. Review priority: UNKNOWN. Active ingredients: OMEPRAZOLE.
Supporting Context
- Therapeutic area
- Gastroenterology · Proton Pump Inhibitor
- Sub-indication
- General
Related signal: FDA Accepts Supplement Application for Omeprazole Magnesium by Marksans Pharma