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Discovery Labs Presents Final Assessment in a Series of Pharmacoeconomic Analyses that Explore Impact of Reintubation on Healthcare Costs
Date:6/11/2013

ded recommendations intended to clarify certain aspects of the updated product specifications and the revalidated analytical chemistry method.  Discovery Labs responded to the FDA on June 7, 2013 and expects that the FDA may require up to four months to review this type of submission.  If the FDA agrees with its submission and responds within the anticipated time, Discovery Labs anticipates that it will proceed with the commercial introduction of SURFAXIN in the fourth quarter of 2013.

IMPORTANT SAFETY INFORMATION

SURFAXIN (lucinactant) intratracheal suspension is intended for intratracheal use only.  The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance.  SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting.  Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.

Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption.  During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized. 

SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).

For more information about SURFAXIN, please visit www.surfaxin.com

ABOUT THE PEDIATRIC PHARMACY ADVOCACY GROUP

The Pediatric Pharmacy Advocacy Group (PPAG) is an international, nonprofit, professional association representing the interests of pediatric pharmacists and their patients. PPAG is dedicat
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SOURCE Discovery Laboratories, Inc.
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