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Cooper Biomedical's alpha 1-antitrypsin

Executive Summary

FDA granted orphan designation to the product for emphysema of genetic origin and for use as supplementation therapy for deficient members of the ZZ phenotype population in 1985. "The Pink Sheet" (Nov. 3, p. 13) incorrectly cited Transgene's product as having received orphan status. In addition, Cooper, not Transgene, began clinicals for use in emphysema in 1984.
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PS011100

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