Newborn Health

Surfaxin receives positive opinion from European orphan drug evaluation agency

Published in Medical Letter on the CDC and FDA, August 8th, 2004

Discovery Laboratories, Inc., (Nasdaq:DSCO) announced that the Committee for Orphan Medicinal Products (COMP) Of The European Agency for the Evaluation of Medicinal Products (EMEA) has adopted a positive opinion recommending the granting of orphan medicinal product designation for Surfaxin.

Surfaxin assists with the prevention and treatment of respiratory distress syndrome (RDS) in premature infants. In assessing Surfaxin for orphan drug designation, the COMP concluded that although satisfactory methods of prevention and treatment of RDS have been authorized in Europe, justifications have been provided that Surfaxin may be of significant benefit to those at risk of...

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Source: Medical Letter on the CDC and FDA (2004-08-08)

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