In another setback for Surfaxin, Discovery Labs announced that it is pulling its marketing application in Europe because of manufacturing issues that prohibit it from meeting the EMEA's timetable. Further trials may be needed before a new application can be filed, according to the company. Discovery Labs already faced hang-ups in the U.S. for Surfaxin, which was developed to treat respiratory distress syndrome in infants. The FDA issued a follow-up approvable letter for the drug that requires Discovery Labs to address questions about the drug's stability.
- read this report on Surfaxin from the Philadelphia Business Journal