Vanda Puts Dog Studies In Spotlight In Suit Challenging FDA Clinical Hold
Vanda seeks court order requiring US FDA to lift partial clinical hold on its gastroparesis treatment tradipitant; calls on drug makers to oppose agency's animal research policy, saying it requires unjustified killing of dogs.
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Vanda Is 1-1 In Fights With FDA As Court Grants Its FOIA Request For Review Documents
Court finds the agency and public would not be harmed if FDA turns over its clinical and statistical reviews of Vanda’s application for Hetlioz jet lag indication. Battles continue over FDA approval of generic Hetlioz and agency’s proposal to refuse the jet lag sNDA.
Absence Of Braille In Generic Hetlioz Label Merits Its Withdrawal, Vanda Lawsuit Argues
Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.
Vanda May Go Another Round With US FDA Over Hetlioz Jet Lag Indication
Agency offers Vanda chance to request a hearing over its plan to refuse to approve its supplemental new drug application. Such a hearing seems unlikely given FDA’s rejection of past requests and Vanda’s track record with the agency.