STN: BL 125248
Proper Name: Thrombin, topical (Recombinant)
Manufacturer: ZymoGenetics, Inc, License #1758
- 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 (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. (1)
March 15, 2013 Approval Letter - RECOTHROM
STN: BL 125248/370, pediatric indication for use of RECOTHROM in children ages 1 month to 16 years.
- Final Clinical Labeling Memo, February 21, 2013 - RECOTHROM (PDF - 52KB)
Clinical Review Memo, Pediatric Study, May 4, 2011 - RECOTHROM(PDF - 206KB) January 17, 2008 Approval Letter - RECOTHROM Approval History, Letters, Reviews and Related Documents - RECOTHROM
FDA Online Label Repository
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- Press Release: FDA Approves First Clotting Solution Made Using Recombinant DNA Technology [ARCHIVED]