Vanda takes issue with FDA's relay of deficiencies for new Hetlioz indication
Vanda Pharmaceuticals said on Monday that the FDA notified the company of several deficiencies in the supplemental new drug application for its insomnia medication Hetlioz, which means the agency cannot approve the drug immediately.
The new indication for Hetlioz — to treat insomnia characterized by difficulties with sleep initiation — ran into a roadblock, but Vanda said that the FDA did not disclose any deficiencies to the company and this is not a formal decision.
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