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.

FDA Approval History for Recothrom

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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