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On
February 6, 2009, the US food and drug administration (FDA) has
issued its first approval for a biological product, Atryn, produced
by genetically engineered animals. Atryn is a therapeutic protein
derived from the milk of goats that have been genetically engineered
by introducing a segment of DNA into their genes (called a recombinant
DNA or rDNA construct) with instructions for the goat to produce
human antithrombin in its milk. Antithrombin is a protein that naturally
occurs in healthy individual and helps to keep blood from clotting
in the veins and arteries.
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The
product offers an important new treatment option for patients with
hereditary antithrombin deficiency, preventing life-threatening clots
that otherwise frequently occur during high risk situations".
The drug
previously received approval from the European Medicines Agency
for use in preventing clotting conditions during surgical procedures
in patients with hereditary antithrombin deficiency.
To get
more details, please go to:
www.fda.gov/bbs/topics/NEWS/2009/
NEW01952.html
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