Mallinckrodt Loses ADHD Drug Lawsuit Against FDA
A U.S. district court in Maryland has let stand the FDA’s November 2014 decision to revoke Mallinckrodt’s equivalence rating for its generic version of Janssen’s ADHD drug Concerta.
The agency notified Mallinckrodt on Nov. 12 that its methylphenidate HCl ER tablets may not be therapeutically equivalent to Concerta after reviewing nearly 200 adverse event reports.
A week later, Mallinckrodt sued, claiming the FDA acted without prior notice or an opportunity for comment.
In ruling on Mallinckrodt Inc. v. United States Food and Drug Administration, et al., Judge Deborah Chasanow sided with the FDA on two counts and dismissed three others.
Mallinckrodt is considering an appeal to the U.S. Court of Appeals for the Fourth Circuit. The FDA does not comment on pending litigation. — Jonathon Shacat