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In Brief: Forest Labs' Infasurf

Executive Summary

Forest Labs' Infasurf: NDA filed March 13 for calf lung surfactant for prevention and treatment of respiratory distress syndrome in premature infants. The product would compete in the RDS market with Abbott's Survanta, also a calf lung product, and Burroughs Wellcome's Exosurf, which is synthetic. The NDA is based on Phase III trials in approximately 1,000 infants. The product has been available in the U.S. under a Treatment IND and has been used to treat more than 10,000 infants. Forest has been touting Infasurf as a superior product based on its effects, which last longer, and the fact that fewer doses are needed compared to other lung surfactants...

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