Discovery Labs Provides Guidance On FDA Approvable Letter for Surfaxin for RDS

Discovery Laboratories, Inc. on May 1, 2008 received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Discovery Labs' Manufacturing, Quality and Regulatory management have performed an assessment of the remaining conditions set forth in the Approvable Letter that must be satisfied to gain U.S. marketing approval for Surfaxin.

The details can be read here.