Nonrulemaking

Request that the FDA, acting through its Center for Veterinary Medicine ("CVM"), exercise its post-approval oversight authority to impose enforceable safe-use conditions for Librela (bedinvetmab injection) (NADA 141-562), a caninized monoclonal antibody approved for the control of pain associated with osteoarthritis in dogs

🏛 Food and Drug Administration (FDA)FDA-2026-P-6249

Animal Health & Welfare Pharmaceutical Policy Product Safety & Recalls

Documents

34

Total comments

385

9 awaiting analysis

Comment status

Open

Last activity

Jul 28, 2026

In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

All 34 Supporting & Related Material 32 Other 2

📄 Primary document

Supporting & Related MaterialJul 14, 2026

javma-javma.26.03.0170

Supporting & Related Material· Jul 14, 2026
Amendment to data presented in EXHIBIT 13 (7.9.2026)→
Supporting & Related Material· Jul 14, 2026
Librela All Cases (updated based on Q1 2026 data pub by FDA JSON)→
Other· Jun 3, 2026
Citizen Petition from Pharmaceutical Safety Oversight Council→
No comment period💬 385
Supporting & Related Material· Jun 3, 2026
Exhibit 09(b) - Librela (bedinvetmab injection) US Prescribing Information Revised (January2025)→
Supporting & Related Material· Jun 3, 2026
Exhibit 09(c) - Librela (bedinvetmab injection) Client Information Sheet→