FIBRYGA

STN# 125612
Proper Name: Fibrinogen (Human)
Tradename: FIBRYGA
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Indication:

FIBRYGA is a human fibrinogen concentrate indicated for:

• fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency
• treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Limitations of Use:

• FIBRYGA is not indicated for dysfibrinogenemia

Product Information

• Package Insert - FIBRYGA
• Demographic Subgroup Information - Fibrinogen Concentrate (Human)
  Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

• June 23, 2025 Approval Letter - FIBRYGA
• July 31, 2024 Clinical Review Memo-FIBRYGA
• July 31, 2024 Statistical Review Memo-FIBRYGA
• July 31, 2024 Approval Letter - FIBRYGA
• Clinical Review - FIBRYGA
• Statistical Review (125612/67) -FIBRYGA
• Clinical Pharmacology Supplemental Review - FIBRYGA
• December 23, 2020 Approval Letter - FIBRYGA
• June 7, 2017 Approval Letter - FIBRYNA
• June 9, 2017 Summary Basis for Regulatory Action - FIBRYNA
• Statistical Review - FIBRYNA
• Approval History, Letters, Reviews, and Related Documents - FIBRYNA