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Discovery Labs revives its US hopes for Surfaxin

This article was originally published in Scrip

Executive Summary

Discovery Laboratories says its troubled Surfaxin (lucinactant) is back on track to get approved by the US FDA for the prevention of respiratory distress syndrome (RDS) in premature infants, provided that it runs a limited clinical trial to assess the pharmacodynamics of the drug. This news reverses guidance from the company two months ago, stating that the drug looked unlikely to get the green light in the US because the FDA was concerned that the marketed drug would not be the same as the drug that had been tested in clinical trials.


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