Vanda Warning Letter From US FDA Leaves Firm "Puzzled"
CEO Polymeropoulos tells the Pink Sheet that both subject and severity of letter regarding description of products on corporate website seem like an overreaction by the agency.
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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.
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.
Vanda Sues US FDA For Documents Backing Complete Response For Hetlioz Jet Lag Indication
FOIA exemption does not apply to medical and statistical reviews of its sNDA, company claims. It says it needs the information to adapt its development program and determine if the agency made an error.