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Adynovate Approval History

  • FDA approved: Yes (First approved November 13th, 2015)
  • Brand name: Adynovate
  • Generic name: antihemophilic factor (recombinant) pegylated
  • Company: Baxalta Incorporated
  • Treatment for: Hemophilia A

Adynovate (antihemophilic factor (recombinant) pegylated) is a human antihemophilic factor indicated for the control and prevention of bleeding episodes in patients with hemophilia A.

Development History and FDA Approval Process for Adynovate

Dec 27, 2016Approval Shire Announces FDA Approval of Adynovate [Antihemophilic Factor (Recombinant), PEGylated] for Use in Children and Surgical Settings
Nov 13, 2015Approval FDA Approves Adynovate Modified Antihemophilic Factor for Hemophilia A

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