Newspaper article from our research archive:

ZymoGenetics.(BLOOD & BIOLOGICS)

Seattle, WA, April 25 (CBER)

The Advertising and Promotional Labeling Branch (APLB) of FDA's Center for Biologics reviewed information on the website http://www.zymogenetics.com including a press release for Recothrom (Thrombin, Topical (Recombinant)) and concluded that this promotional material is false or misleading because it omits material facts about Recothrom.

Recothrom is a coagulation protein produced via recombinant DNA technology from a genetically modified Chinese Hamster Ovary (CHO) cell line. The "Indications and Usage" section of the FDA-approved labeling (PI) states "RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding ...

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