Vanda Pharmaceuticals Receives CRL From FDA On SNDA For HETLIOZ - Quick Facts

(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA) has received a Complete Response Letter from the FDA as part of ongoing review of supplemental New Drug Application for HETLIOZ in the treatment of insomnia characterized by difficulties with sleep initiation. It was previously reported that the FDA identified deficiencies.

Consistent with the prior notification, the FDA has issued a CRL, indicating that the FDA cannot approve the sNDA in its present form. The company stated that it is reviewing the CRL and evaluating next steps.

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