Details Basic Details Status Ongoing Last Updated Tuesday, November 17, 2020 Original Posting Date Thursday, July 30, 2020 Health Outcome(s) congenital cardiac malformations Purpose Drug and Outcome Analysis Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR No Analytic Code Link(s) (1) Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis Result(s) (2) Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Descriptive Analysis Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis