SPARC reports FDA CRL resubmission for PDP-716 NDA by Ocuvex; primary issues relate to third-party API facility inspections, with no new efficacy or safety concerns raised. Awaiting FDA determination on completeness of the resubmission.
AI Assistant
Sun Pharma Advanced Research Company Ltd
2025
Announcement
Find Answers
Ask about any part of the document to get insights, explanations, or key details.