Mallinckrodt Public Limited Co.’s (MNK) Stannsoporfin injection, proposed for the treatment of newborns at risk of developing severe jaundice, is under FDA review, with a decision expected on August 22, 2018.An FDA panel had voted 21 to 3 against approval of Stannsoporfin in May of this year. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.Stannsoporfin injection was developed by InfaCare Pharmaceutical Corp. Mallinckrodt acquired InfaCare Pharmaceutical last August.Jaundice or hyperbilirubinemia is a common condition seen both in term and pre-term newborns. In the U.S., the total number of term births is estimated at 3.97 million per year, and, of those, approximately 750,000 infants are treated for jaundice, according to reports.MNK closed Wednesday’s (Jul 25) trading at $22.74, up 2.43%.