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In Brief: Forest's Infasurf

Executive Summary

Forest's Infasurf: Lung surfactant for prophylaxis and treatment of respiratory distress syndrome in premature infants is "approvable" as of July 25. Some chemistry and labeling issues remain to be resolved prior to approval, Forest says. FDA must also make a final determination on whether Infasurf is chemically different or clinically superior to Abbott's Survanta, which has market exclusivity from orphan drug protection. Infasurf is calf lung surfactant extract and Survanta is calf extract-derived. Forest believes the data in the NDA (submitted March 13) show that Infasurf is both chemically different and clinically superior to Survanta. At a meeting with analysts in February, Forest CEO Howard Solomon asserted that Infasurf is more effective, lasts longer, and requires less supplementary oxygen and fewer installations than Survanta or Glaxo Wellcome's Exosurf ("The Pink Sheet" Jan. 15, T&G-12)...

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