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Pugilistic Vanda Collects Another NOOH As US FDA Defends Tradipitant Turndown

 
• By Bridget Silverman

Vanda’s fight against a complete response letter for its gastroparesis drug results in a notice of opportunity for hearing on a formal FDA proposal to refuse to approve the NDA.

Can Vanda revive its bid for tradipitant after the FDA revealed its case for refusing approval? (Shutterstock)

Vanda Pharmaceuticals added to its dubious accomplishment as the US Food and Drug Administration’s most oppositional sponsor with a multi-front defense of its gastroparesis candidate tradipitant following a complete response letter, which now has escalated to a notice of opportunity for hearing (NOOH) on an agency proposal to refuse to approve the NDA.

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