Zdrowie i gospodarka · 11/10/2022

FDA Director Proposes to Refuse Approval of Vanda's HETLIOZ Supplement

The FDA Director is proposing to reject Vanda Pharmaceuticals' supplemental new drug application for HETLIOZ (tasimelteon) capsules due to concerns, and offers Vanda the chance to request a hearing on the matter.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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