FDA Urges Court to Dismiss Suit on Generic Sleep Drug Approval

A lawsuit alleging the FDA was wrong when it approved a generic version of a sleep drug is unripe and unfit for review, the agency told a federal court in a legal battle brought on by Vanda Pharmaceuticals Inc.

The Food and Drug Administration opposed Vanda’s challenge that the agency disregarded its own policies and was incorrect to approve MSN Pharmaceuticals Inc.’s abbreviated new drug application for a generic version of Vanda’s tasimelteon, a drug used to treat non-24-hour sleep-wake disorder.

The drugmaker in May 2023 filed a citizen petition urging the FDA to reject MSN’s application, and in September ...