BRIEF-FDA Declines Vanda's Marketing Application For Tradipitant In Gastroparesis

Reuters

2024/09/19

Sept 19 (Reuters) - Vanda Pharmaceuticals Inc :

* FDA DECLINES TO APPROVE VANDA'S MARKETING APPLICATION FOR TRADIPITANT IN GASTROPARESIS

* VANDA PHARMACEUTICALS INC - FDA ISSUES COMPLETE RESPONSE LETTER TO VANDA FOR TRADIPITANT

* VANDA PHARMACEUTICALS INC - FDA SUGGESTS ADDITIONAL STUDIES FOR TRADIPITANT APPROVAL

* VANDA PHARMACEUTICALS INC - TO SUBMIT NDA FOR TRADIPITANT IN MOTION SICKNESS LATER THIS YEAR

* VANDA: BELIEVES TRADIPITANT APPLICATION HAS MET SUBSTANTIAL EVIDENCE OF EFFICACY STANDARD

* VANDA: WILL CONTINUE TO PURSUE MARKETING AUTHORIZATION FOR TRADIPITANT

Source text for Eikon: Further company coverage:

((Reuters.Briefs@thomsonreuters.com;))

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