STORY FROM: Drugs & Medical Devices

Warning Claims Against Makers of Generic RLD Drugs Preempted, Illinois Federal Judge Rules

CHICAGO — Warning-based state law claims asserted against manufacturers of generic testosterone replacement therapy drugs that were approved via the Abbreviated New Drug Application are preempted, despite the fact that the drugs were designated as Reference Listed Drugs, an Illinois federal judge has ruled.

In a Nov. 9 order, Judge Matthew F. Kennelly of the U.S. District Court for the Northern District of Illinois explained that the Food and Drug Administration itself has stated that ANDA RLD holders have no more authority than other ANDA holders to change their labeling unilaterally through the Changes Being Effected Process.

This multidistrict litigation ...

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