WARRINGTON
Nike Lunar Eclipse 2, Pa., April 5 (UPI) -- Discovery Labs said Wednesday it got its second approvable letter from the FDA for its infant respiratory distress drug Surfaxin.
The company said the Food and Drug Administration still has concerns about manufacturing controls for the drug's active ingredient. Discovery must address these issues before obtaining final approval of the treatment
polo ralph lauren outlet, intended to prevent respiratory distress syndrome in premature infants. Discovery said it plans to meet with the FDA to resolve the outstanding issues.
Surfaxin is a peptide-containing, synthetic surfactant, which closely mimics the function of natural human lung surfactant and provides an alternative to surfactants made with bovine and porcine tissue, the company said.
Discovery noted that it satisfied the issues raised in a previous FDA approvable letter regarding Surfaxin last October.
"Our top priority is to satisfy the FDA's requests as soon as possible ... said Discovery President and CEO Robert Capetola. "In light of today's news
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RDS is a life-threatening and costly breathing disorder that affects tens of thousands of premature infants in the United States each year, and more than 500,000 infants worldwide, the company said.
According to Discovery, about 75,000 infants are treated with surfactants in the United States annually.
