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Talecris Biotherapeutics Receives FDA Approval for PROLASTIN(R)-C
Date:10/19/2009

facturing," said Steve Petteway, Ph.D., executive vice president, Research and Development. "Our single-minded goal is advancing the care of patients who rely on our products."

PROLASTIN DIRECT, the exclusive distribution and health management program for PROLASTIN, will provide more information to patients in the U.S. about the transition to PROLASTIN-C. Information about the transition to PROLASTIN-C in other countries will be provided as regulatory approvals are granted.

About PROLASTIN® and PROLASTIN®-C

PROLASTIN and PROLASTIN-C, Alpha1-Proteinase Inhibitor (Human), are derived from human plasma and are administered intravenously to raise the levels of AAT in the blood and lungs. PROLASTIN and PROLASTIN-C are indicated for chronic augmentation and maintenance therapy of individuals having congenital deficiency of alpha-1 PI (alpha1-antitrypsin deficiency) with clinically demonstrable panacinar emphysema. PROLASTIN was the first plasma-derived AAT augmentation therapy to receive approval from the U.S. Food and Drug Administration (FDA) and was approved in December 1987 and launched in February 1988.

Important Safety Information

In clinical studies comparing PROLASTIN-C and PROLASTIN, adverse events (AEs) were reported at a rate of 0.117 and 0.078 per infusion for PROLASTIN-C and PROLASTIN, respectively, with comparable severity of AEs between treatments. The most common drug related adverse reactions during clinical trials in greater than or equal to 1% of subjects treated with PROLASTIN-C were chills, malaise, headache, rash, hot flush and pruritus. The most serious adverse reaction observed during clinical studies with PROLASTIN-C was an abdominal and extremity rash in one subject. In previous clinical studies with PROLASTIN, reactions were observed in 1.16% of infusions, the most common events being fever (0.77%), light-headedness (0.19%), and dizziness (0.19%).

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SOURCE Talecris Biotherapeutics
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