HAUPTMENÜ
AWARDS
Forschergeist gefragt: 14. Novartis Oppenheim-Förderpreis für MS-Forschung ausgelobt
FernstudiumCheck Award: Deutschlands beliebteste Fernhochschule bleibt die SRH Fernhochschule
Vergabe der Wissenschaftspreise der Deutschen Hochdruckliga und der Deutschen Hypertoniestiftung
Den Patientenwillen auf der Intensivstation im Blick: Dr. Anna-Henrikje Seidlein…
Wissenschaft mit Auszeichnung: Herausragende Nachwuchsforscher auf der Jahrestagung der Deutschen…
VERANSTALTUNGEN
Wichtigster Kongress für Lungen- und Beatmungsmedizin ist erfolgreich gestartet
Virtuelle DGHO-Frühjahrstagungsreihe am 22.03. / 29.03. / 26.04.2023: Herausforderungen in…
Pneumologie-Kongress vom 29. März bis 1. April im Congress Center…
Die Hot Topics der Hirnforschung auf dem DGKN-Kongress für Klinische…
Deutscher Schmerz- und Palliativtag 2023 startet am 14.3.
DOC-CHECK LOGIN
FDA approves Surfaxin to prevent breathing disorder in premature infants
Silver Spring, MD, USA (March 6, 2012) – The U.S. Food and Drug Administration today approved Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants.
The lungs of premature infants are not able to make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse and the infant has difficulty breathing. Most babies who develop RDS show signs of breathing problems and a lack of oxygen at birth or within the first few hours after birth.
Surfaxin is the fifth drug approved in the United States to treat RDS in premature infants. The other FDA-approved surfactants include Survanta (beractant), Curosurf (poractant alpha), Infasurf (calfactant), and Exosurf (colfosceril palmitate), which is no longer marketed.
A single randomized, active-controlled, multi-dose study involving 1,294 premature infants demonstrated the safety and efficacy of Surfaxin. Within 30 minutes of birth, infants in the study received either Surfaxin, Exosurf or Survanta. Surfaxin and Exosurf served as the primary comparison for this study; Survanta served as another comparison. Surfaxin demonstrated significant improvement in both RDS at 24 hours after birth and RDS-related mortality through two weeks, when compared with Exosurf.
The most common side effects of Surfaxin are related to its administration down a premature infant’s breathing tube (endotracheal tube) and include endotracheal tube reflux, skin paleness, endotracheal tube obstruction, and need for dose interruption.
Surfaxin is manufactured by Discovery Laboratories Inc. of Warrington, Pa.
For more information
-
National Heart, Lung and Blood Institute: What Is Respiratory Distress Syndrome? – http://www.nhlbi.nih.gov/health/health-topics/topics/rds/
-
Approved Drugs: Questions and Answers – http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
U.S. Food and Drug Administration (FDA), 06.03.2012 (tB).