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Discovery Laboratories (DSCO) Provides Update Regarding Its Program for Surfaxin(R) U.S. Marketing Authorization
1/10/2011 10:14:08 AM
WARRINGTON, Pa., Jan. 10, 2011 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCOD), a biotechnology company developing its novel, synthetic, peptide-containing surfactant, is providing an update regarding its efforts to file a Complete Response intended to gain U.S. Food and Drug Administration (FDA) marketing authorization of Surfaxin® for the prevention of respiratory distress syndrome (RDS) in premature infants. Discovery Labs has had multiple interactions with the FDA regarding various aspects of the final validation of an important quality control release and stability test for Surfaxin, the fetal rabbit biological activity test (BAT). In response to a proposal submitted by Discovery Labs, the FDA has recently provided detailed, written direction regarding the verification of certain parameters related to final BAT validation. The FDA indicated that several aspects of Discovery Labs' proposed approach to the BAT validation are reasonable; however, with respect to certain parameters, the FDA is requesting additional data to further support ultimate determination of BAT validation.
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