Vanda Sues FDA For ‘Cutting Corners’ On MSN’s Generic Hetlioz Approval

Patient Population For MSN’s Generic Tasimelteon Targeted In New US Suit

Looking to take the FDA to court again, Vanda Pharmaceuticals has sued the agency for the way in which it evaluated and approved MSN Pharmaceuticals’ generic version of its sleep-wake disorder drug Hetlioz.

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Indian generics manufacturer MSN Pharmaceuticals’ recent US Food and Drug Administration approval for a generic version of Vanda Pharmaceuticals’ Hetlioz (tasimelteon) was “unlawful and poses serious safety risks to public health,” because the agency in approving it disregarded its own “accepted principles of bioequivalence,” according to a lawsuit filed against the FDA by the originator.

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