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Discovery Laboratories, Inc. today announced that it has 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
Warrington, PA, USA | May 2, 2008 | Discovery Laboratories, Inc. (Nasdaq: DSCO) today announced that it has 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. This official notification sets forth the remaining conditions that must be satisfied to gain U.S. marketing approval for Surfaxin.
The Approvable Letter was received in the evening of May 1, 2008, the PDUFA date that had been established for Surfaxin. Prior to receiving this Approvable Letter, Discovery Labs had finalized Surfaxin labeling discussions with the FDA. In addition, the FDA had completed its pre-approval inspection of Discovery Labs’ manufacturing facility in Totowa, NJ and recently issued an Establishment Inspection Report (EIR) reflecting a successful inspection.
Discovery Labs is assessing the Approvable Letter and will contact the FDA within the next few days to discuss required actions and timing to gain Surfaxin approval. Discovery Labs expects to be in a position early next week to provide guidance regarding its plans and timeline considerations to address the Approvable Letter.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs’ technology produces a peptide-containing synthetic surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. Discovery Labs believes that, with its proprietary technology, SRT has the potential, for the first time, to advance respiratory medicine and address a variety of respiratory diseases affecting neonatal, pediatric and adult patients.
Discovery Labs’ lead product candidate, Surfaxin(R), is the subject of an Approvable Letter from the FDA for the prevention of Respiratory Distress Syndrome in premature infants. Surfaxin is also being developed for other neonatal and pediatric indications. Aerosurf™, Discovery Labs’ aerosolized SRT, is being developed to potentially obviate the need for intubation and
conventional mechanical ventilation and holds the promise to significantly expand the use of surfactants in respiratory medicine.
SOURCE: Discovery Laboratories, Inc. |
