Vanda May Go Another Round With US FDA Over Hetlioz Jet Lag Indication
Agency offers Vanda chance to request a hearing over its plan to refuse to approve its supplemental new drug application. Such a hearing seems unlikely given FDA’s rejection of past requests and Vanda’s track record with the agency.
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Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements
Vanda says FDA improperly requires it to disprove all alleged deficiencies in its Hetlioz application for jet lag. Contentious approach to notice of opportunity for hearing contrasts with that of Intarcia and Lexicon, which also seek hearings over FDA’s proposal to refuse their applications.
Covis, CDER Lay Out Arguments Ahead Of Makena’s Accelerated Approval Withdrawal Hearing
The company seeks to keep Makena on the market with a narrower indication while it conducts a new randomized, controlled trial in the US, but the FDA’s drugs center says keeping the drug on the market would render a new trial infeasible and do a disservice to women at risk for preterm birth.
US FDA Continues Shutout Of Companies Seeking Drug Rejection Hearings
Intarcia and Lexicon fail to convince FDA's Center for Drug Evaluation and Research to grant hearings after complete response letters. Intarcia contends that kidney injury with its diabetes drug implant is similar to Novo Nordisk’s Wegovy, while Lexicon argues that CDER did not adequately consider a REMS when reviewing its SGLT2 inhibitor.