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- A government court gave last judgment for Vanda Pharmaceuticals Inc’s VNDA Flexibility of Info Act (FOIA) situation asking for documents developed by the FDA throughout its evaluation of Vanda’s application looking for authorization of Hetlioz (tasimelteon).
- DC Area Court Court gave Vanda Pharma’s demand to need the FDA to reveal even more information on the full feedback letter for its rest condition medicine Hetlioz.
- Additionally Check Out: Vanda Pharma’s Antipsychotic Reveals Improved Seriousness In Bipolar Affective Disorder
- Vanda submitted the legal action to force the FDA to generate particular documents connecting to its rejection of Vanda’s extra advertising application for Hetlioz for the jet lag condition.
- In 2018 Vanda submitted a supplementary application to market Hetlioz as a therapy for jet lag, which the FDA turned down in 2019 and also rejected to reveal those documents.
- Vanda took legal action against in April 2022, claiming it has a right to recognize what else the being rejected and also evaluation records have.
- As component of its judgment, the government court provided a last and also triable order in Vanda’s support, refuting the FDA’s cross-motion for recap judgment.
- Rate Activity: VNDA shares shut at $6.79 on Tuesday.
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