Vanda’s sNDA for Hetlioz rejected again by FDA
US drugmaker Vanda Pharmaceuticals (Nasdaq: VNDA) yesterday announced that it has received a decision letter from the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form.
This letter stems from CDER's agreed re-review of the jet lag application under the October 1 collaborative framework agreement. Vanda’s shares dropped by 11%, settling at $7.55.
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