FDA OKs novel surgical clotting solution

Jan 17, 2008

The U.S. Food and Drug Administration announced approval Thursday of the first clotting solution made using recombinant DNA techniques.

The FDA said the new solution, called Recothrom, is a topical solution designed to stop small blood vessels from bleeding following surgery. Recombinant DNA is the result of a genetic modification process that enables scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

The FDA said post-surgical bleeding from small blood vessels, such as capillaries, can cause significant blood loss. Physicians can apply Recothrom during surgery when standard surgical techniques for stopping blood loss are ineffective or impractical.

"With today's approval, surgeons can choose recombinant thrombin, thrombin derived from human plasma or thrombin derived from cattle plasma to help control surgical bleeding and oozing," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.

Recothrom is made from Chinese hamster ovary cells that have been genetically modified to produce human thrombin. The cells are free from known infectious agents, the FDA said, noting Recothrom undergoes an additional process of viral inactivation.

Recothrom is manufactured by ZymoGenetics Inc. of Seattle.

Copyright 2008 by United Press International

Explore further: New drug sales help boost Novartis Q1 profit (Update)

add to favorites email to friend print save as pdf

Related Stories

FDA OKs new adhesive to treat burn victims

Mar 20, 2008

The U.S. Food and Drug Administration approved a medical adhesive -- a fibrin sealant called Artiss -- for use in attaching skin grafts to burn patients.

Recommended for you

Amgen misses 1Q views as higher costs cut profit

Apr 22, 2014

Despite higher sales, biotech drugmaker Amgen's first-quarter profit fell 25 percent as production and research costs rose sharply, while the year-ago quarter enjoyed a tax benefit. The company badly missed ...

Valeant, Ackman make $45.6B Allergan bid

Apr 22, 2014

Valeant Pharmaceuticals and activist investor Bill Ackman have unveiled details of their offer to buy Botox maker Allergan, proposing a cash-and-stock deal that could be worth about $45.6 billion.

User comments : 0

More news stories

New breast cancer imaging method promising

The new PAMmography method for imaging breast cancer developed by the University of Twente's MIRA research institute and the Medisch Spectrum Twente hospital appears to be a promising new method that could ...

Breast cancer replicates brain development process

New research led by a scientist at the University of York reveals that a process that forms a key element in the development of the nervous system may also play a pivotal role in the spread of breast cancer.

Research proves nanobubbles are superstable

The intense research interest in surface nanobubbles arises from their potential applications in microfluidics and the scientific challenge for controlling their fundamental physical properties. One of the ...

Using antineutrinos to monitor nuclear reactors

When monitoring nuclear reactors, the International Atomic Energy Agency has to rely on input given by the operators. In the future, antineutrino detectors may provide an additional option for monitoring. ...