Posted by Michael Wonder on 24 Feb 2018
Mallinckrodt receives FDA acceptance of stannsoporfin new drug application filing
23 February 2018 - Action date set for 22 August 2018.
Mallinckrodt today announced the U.S. FDA has accepted its new drug application seeking approval of its recently acquired developmental product stannsoporfin.
If approved, the drug is expected to become the first and only pharmacologic option in the U.S. indicated for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.
