Vanda announces FDA accepted tradipitant NDA for motion sickness; PDUFA Dec 30, 2025; firm criticizes timeline

Vanda Pharmaceuticals Inc.

FDA accepted for filing Vanda's NDA for tradipitant to treat motion sickness; PDUFA target date set for December 30, 2025.
Vanda says FDA intends to take 12 months for review, 6 months beyond the statutory deadline, calling it a violation of the FD&C Act.
Clinical data from pooled studies (681 subjects): vomiting in 14.6% (170 mg) and 18.9% (85 mg) vs 41.2% placebo, p<0.0001.
Vanda publicly criticized the FDA as 'broken and unaccountable' for allegedly stifling innovation and delaying approval.

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