Vanda sues FDA yet again, accuses federal agency of delaying post-CRL hearing
Vanda Pharmaceuticals has filed yet another lawsuit against the FDA — and once again related to the drug it’s hoping to expand into jet lag disorder.
The serial plaintiff accused the agency of failing to give Vanda a hearing to determine if it can add a jet lag disorder indication to Hetlioz, Vanda’s FDA-approved drug to treat Non-24, a circadian rhythm disorder in which a patient’s internal clock is mismatched to the 24-hour day/night cycle.
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