FESILTY

STN: BLA 125833
Proper Name: fibrinogen, human–chmt
Tradename: FESILTY
Manufacturer: Grifols Therapeutics, Inc.
Indications:

• Fibrinogen, human–chmt is indicated for treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.

Product Information

• Package Insert - FESILTY

Supporting Documents

• December 16, 2025 Approval Letter - FESILTY
• December 16, 2025 Summary Basis for Regulatory Action - FESILTY
• Letters, Reviews, and Related Documents – FESILTY