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Adynovate FDA Approval History

FDA Approved: Yes (First approved November 13, 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 timeline 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

Further information

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