The U.S. Food and Drug Administration (FDA) approved SURFAXIN® for the prevention of RDS in premature infants who are at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal derived surfactants.
In the third quarter of 2012, during a routine review of our processes related to analytical testing and quality control of SURFAXIN drug product, Discovery Labs determined that one analytical chemistry method used to assess SURFAXIN drug product required improvement and that an update to SURFAXIN product specifications was needed. Discovery Labs notified the FDA, improved and revalidated the analytical chemistry method, and submitted updated product specifications to the FDA. In
, the FDA requested information and provided 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.