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Company Case Management / Clinical Program ViroPharma Inc. / AEs / ViroPharma Inc. / C1 / Lev Pharmaceuticals / / Continent Europe / / Country United States / / Event FDA Phase / Product Issues / / IndustryTerm reactive site / blood products / fibrinolytic systems / parallel / open-label study product / blood product / aqueous solution / glycol solution / cascade systems / manufacturing process / / MedicalCondition allergic reaction / laryngeal edema / inflammatory process / Narcotic Addiction / HAE / hereditary angioedema / angioedema / angioedema attacks / deficiency / angioedema attack / / Organization office of Compliance and Biologics Quality / FDA / Administration of Cinryze / Approval Approval Basil Golding____________________________ Offices Signatory Authority / Division of Case Management / One Unit / / Person Iftekhar Mahmood / L. Ross Pierce / Boris Zaslavsky / Lot Release / Nannette Cagungun / / / Position investigator / Alpita Popat Regulatory Project Manager / clinical investigator / Chair / Committee / Chair Committee / / Product polyethylene glycol / INH / Sterile Water for Injection / C1-INH / LEVP2006-4 / C1INH / Cinryze / / Technology Pharmacokinetics / Treatment Plan The protocol / 3 protocol / / SocialTag 
SBRA STN[removed]Summary Basis for Regulatory Action Date