Vanda Sues FDA Over Approval of Generic Rival Sleep Medicine

Vanda Pharmaceuticals Inc. sued the Food and Drug Administration on Monday over the agency’s approval of a generic drug application for a sleep medication from one of its competitors.

Vanda, which sells Hetlioz, a medication to treat non-24-hour sleep-wake disorder, filed suit in the US District Court for the District of Columbia alleging the FDA unlawfully approved MSN Pharmaceuticals’ abbreviated new drug application for its generic tasimelteon without the proper bioequivalence studies, which could pose serious safety risks to public health.

Generic drug applications must show the proposed product is bioequivalent, or biochemically similar, to an FDA-approved name brand reference ...