Judge Tosses Vanda Generic Sleep Drug Approval Suit Against FDA

A lawsuit filed by Vanda Pharmaceuticals Inc. alleging the FDA was wrong when it approved a generic version of the sleep drug Hetlioz is unripe and unfit for review, a federal judge ruled.

Vanda’s lawsuit challenging the agency’s approval of MSN Pharmaceuticals, Inc.’s generic sleep-disorder drug tasimelteon lacks ripeness and fails to exhaust mandatory administrative remedies, Judge Christopher R. Cooper for the US District Court for the District of Columbia wrote in a Tuesday order.

Vanda in September 2023 filed a lawsuit against the agency alleging it violated the Administrative Procedure Act when it approved MSN’s product with improper ...