Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, confirmed today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) for stannsoporfin.
In the letter, the Agency provided guidance regarding areas of further evaluation for resubmitting the stannsoporfin NDA for the treatment of newborns ≥35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe jaundice, or hyperbilirubinemia.
“The letter from the FDA was not unexpected following the outcome at the recent Advisory Committee meeting,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer. “We are evaluating the Agency’s guidance and will request a meeting with the FDA in the coming months to discuss potential paths forward.”
Until that discussion, Mallinckrodt does not expect to make a decision related to future efforts or investment in the developmental product.
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