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In Brief: Organon's Orgaran

Executive Summary

Organon's Orgaran: Injectable danaparoid sodium for prevention of deep vein thrombosis in elective hip surgery is "approvable" at FDA as of July 24. The company's Cotazym pancrelipase capsule also "approvable" as of July 19; FDA had requested the submission of an NDA for the pancreatic enzyme product, which already is marketed by Organon. Both products should be approved shortly pending resolution of general labeling issues, company states...
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