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FDA approves ZymoGenetics’s hemostasis drug

ZymoGenetics has reported that the FDA has approved Recothrom Thrombin, topical for sale.

Under a global collaboration, Bayer HealthCare Pharmaceuticals will support the launch of Recothrom in the US for three years. The FDA approval triggers a $40 million milestone payment from Bayer HealthCare to ZymoGenetics. ZymoGenetics will compensate Bayer HealthCare for its US sales efforts by paying a tiered commission of up to 20% on US sales and up to $20 million in sales bonus payments upon achievement of certain US sales levels during a three-year co-promotion period.

Recothrom, previously referred to as recombinant thrombin (rThrombin), is said to be the first and only recombinant, plasma-free thrombin approved for use as a topical hemostat. Recothrom is 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.