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.
Pugilistic Vanda Collects Another NOOH As US FDA Defends Tradipitant Turndown
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.
