April 20, 2009 -- Discovery Laboratories, Inc. today announced that, on April 17, 2009, it received a Complete Response letter from the U.S. FDA for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome in premature infants. In its letter, the FDA focuses primarily on certain aspects of a Surfaxin biological activity test (BAT, a quality control stability and release test) that must be addressed before the Surfaxin application can be approved.
The details can be read here.
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