Austin, Tx 3/7/12 (StreetBeat) -- The fifth time was indeed the charm for Discovery Laboratories Inc. (Nasdaq: DSCO), which on Tuesday received marketing approval for Surfaxin from the Food and Drug Administration.Surfaxin is a synthetic surfactant product developed by the Warrington, Pa., biopharmaceutical company to prevent respiratory distress syndrome (RDS) in premature infants.
Discovery labs first sought approval from the FDA for the compound in 2004. The company endured four requests for more information from the agency prior to getting the drug approved.
I chronicled the company’s long and arduous path to approval this week in the Philadelphia Business Journal.
“The approval of Surfaxin is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS,” said W. Thomas Amick, chairman and CEO of Discovery Labs. “This is a significant milestone in our continuing efforts to develop a pipeline of products to further advance the standard of respiratory critical care.”
The company anticipates that Surfaxin will be commercially available in the United States later this year.
About 90,000 premature infants in the United States are treated annually with animal-derived surfactants.
The FDA granted Discovery Labs its first-ever product approval last month when it granted marketing clearance to the company’s Afectair technology developed to simplify delivery of aerosolized medications to patients requiring ventilator support.
Discovery Labs’ stock was trading up 5 percent, to $3.75 per share, Tuesday afternoon before trading was halted pending the announcement of the FDA’s decision on the company’s new drug application for Surfaxin.
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