Tradename: COAGADEX
Proper Name: Coagulation Factor X, (human)
Indication: To expand the indication for perioperative management of bleeding to include patients with severe hereditary Factor X deficiency based on submission of the final study report for Study TEN06, intended to fulfill the Postmarketing Commitment
Indicated in adults and children with hereditary Factor X deficiency for:
Routine prophylaxis to reduce the frequency of bleeding episodes
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding in patients with mild, moderate and severe hereditary Factor X deficiency
Approval Date: 04/14/2023
Manufacturer: Bio Products Laboratory Limited
More: https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/coagadex