Discovery Laboratories (DSCO) Submits Response To FDA Approvable Letter For Surfaxin For RDS In Premature Infants
10/19/2005 5:09:04 PM
WARRINGTON, Pa., July 29, 2005 (PRIMEZONE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), today announced that it has submitted its response to the Approvable Letter received from the U.S. Food and Drug Administration (FDA) for Surfaxin(R) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The Company believes that the response addresses the comments noted in the Approvable Letter by providing the FDA with the information necessary to complete its review of the Surfaxin New Drug Application (NDA) within six months.
In February 2005, the FDA issued an Approvable Letter indicating that it is prepared to approve the NDA when issues noted in the letter are adequately addressed. Most importantly, the FDA is not requiring additional preclinical or clinical studies. The Approvable Letter addressed certain labeling, chemistry, and manufacturing issues. With respect to Discovery's contract manufacturer, Laureate Pharma, Inc. (Laureate), the FDA previously issued a Form 483, citing inspectional observations related to compliance with current Good Manufacturing Practices (cGMPs) and other processes to be used for commercial production of the product. The general theme of the observations related to basic quality controls, process assurances and documentation requirements that support the commercial production process.