Regeneron Pharmaceuticals Inc: Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single…
| Source | FDA · Drugs (US) |
|---|---|
| Date | 2026-08-26 |
| Product | Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01 |
| Reason / hazard | Lack of Assurance of Sterility |
| Classification | Class II |
| Official notice | — |
| Record ID | fda-drug:D-0767-2026 |