FDA issues CRL for pedatric jaundice drug stannsoporfin

23 August 2018

The US Food and Drug Administration yesterday issued a Complete Response Letter related to the New Drug Application (NDA) for stannsoporfin.

In the letter to the drug’s developer, UK-incorporated specialty biopharmaceutical firm Mallinckrodt (NYSE: MNK), 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 company’s shares fell 2.17% to $35.19 by close of trading on Wednesday.

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