The Food and Drug administration approved
Evithrom, a protein used to control bleeding during surgery, making it the first human thrombin product cleared since 1954.
The blood-clotting protein is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins when standard surgical techniques are ineffective or impractical. Evithrom will be distributed by
Johnson & Johnson
. The FDA made the announcement on its Web site.
The approval was timely for Omrix, beating competitor
, which said last week that the FDA
would take longer to review its competing thrombin agent.
"The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding," said Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research in an agency release. "Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma."
Shares of Omrix rose $2.38, or 8.9%, to $31.60, while ZymoGenetics gave up 67 cents, or 5.5%, to $11.52.