Vanda Pharmaceuticals Aktie
WKN DE: A0JJT3 / ISIN: US9216591084
18.08.2025 14:13:27
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Vanda Pharmaceuticals: Appeals Court Overturns FDA's Order On Hetlioz
(RTTNews) - Vanda Pharmaceuticals (VNDA) said it secured a victory over the FDA in its dispute with the agency regarding the approvability of HETLIOZ or tasimelteon to treat jet lag disorder. The Court has remanded the case back to the FDA, where Vanda anticipates the FDA will either approve the sNDA or Vanda will receive a hearing.
Vanda submitted its supplemental New Drug Application in 2018 to market HETLIOZ to treat jet lag disorder. The court ordered the FDA to resolve Vanda's sNDA or commence a hearing.
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Vanda Pharmaceuticals IncShs | 4,52 | 3,67% |
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