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Coagadex Approval History

  • FDA approved: Yes (First approved October 20th, 2015)
  • Brand name: Coagadex
  • Generic name: coagulation factor X (human)
  • Dosage form: Injection
  • Company: Bio Products Laboratory Limited
  • Treatment for: Hereditary Factor X Deficiency

Coagadex (coagulation factor X (human)) is a human factor X concentrate for the treatment of hereditary factor X deficiency.

Hereditary factor X deficiency is a rare bleeding disorder caused by a lack of clotting factor X in the blood. Coagadex is a plasma-derived blood coagulation factor X concentrate used to treat patients 12 years and older with mild hereditary factor X deficiency for the control of bleeding episodes, and perioperative management of bleeding.

Allergic type hypersensitivity reactions, including anaphylaxis, are possible with Coagadex. Patients should stop treatment and contact their healthcare provider right away if they experience any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash or hives. Coagadex is contraindicated in patients with known hypersensitivity to any of the components of the product.

Coagadex is made from human plasma and may contain infectious agents such as viruses and, theoretically, the Creutzfeldt-Jakob disease agent. No cases of transmission of viral diseases, vCJD or CJD, have been associated with the use of Coagadex.

In clinical studies, the most common side effects (frequency ≥5% of subjects) of Coagadex were infusion site erythema, infusion site pain, fatigue and back pain.

Development History and FDA Approval Process for Coagadex

DateArticle
Oct 20, 2015Approval FDA Approves Coagadex (coagulation factor X (human)) for Hereditary Factor X Deficiency
May 27, 2015FDA Accepts BPL’s Amended BLA Submission for Coagadex (Coagulation Factor X, Human)

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