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Recothrom Approval History

  • FDA approved: Yes (First approved January 17th, 2008)
  • Brand name: Recothrom
  • Generic name: Thrombin, topical (Recombinant)
  • Previous name: rhThrombin
  • Company: ZymoGenetics, Inc.
  • Treatment for: Hemostasis During Surgery

Recothrom is a recombinant form of human thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. Recothrom may be used in conjunction with an absorbable gelatin sponge, USP.

Development History and FDA Approval Process for Recothrom

Jan 17, 2008Approval FDA Approves ZymoGenetics' Recothrom Thrombin, topical (Recombinant)
Feb 15, 2007FDA Accepts ZymoGenetics' Recombinant Human Thrombin Application for Review
Dec 18, 2006ZymoGenetics Submits BLA to the FDA for rhThrombin as an Aid to Controlling Bleeding During Surgery

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