FDA denies hearing to Vanda on jet lag indication for sleep disorder drug
Vanda Pharmaceuticals said on Monday that the FDA notified the company of several deficiencies in the supplemental new drug application for its insomnia medication Hetlioz, which means the agency cannot approve the drug immediately.
WASHINGTON, May 10, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today responded to the ruling in its Hetlioz® Abbreviated New Drug Application appeal.
WASHINGTON, March 28, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced a win in its jet lag FOIA litigation against the FDA.
MSN's Generic Tasimelteon Receives Approval in the U.S.
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The clock is ticking on Vanda Pharmaceuticals’ sleep disorder drug Hetlioz—and, Tuesday, it got louder.
It’s not often that the FDA publicly explains the rationale behind its rejections, but the company the FDA is now opening up about has a litigious history with the federal regulator.
WASHINGTON, Sept. 7, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) ( Nasdaq: VNDA) today announced the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) to treat jet lag disorder.