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Vanda Sues US FDA For Documents Backing Complete Response For Hetlioz Jet Lag Indication

 
• By Brenda Sandburg

FOIA exemption does not apply to medical and statistical reviews of its sNDA, company claims. It says it needs the information to adapt its development program and determine if the agency made an error.

Jet lag
Vanda fights FDA for documents pertaining to jet lag indication for Hetlioz • Source: Alamy

Nearly three years after receiving a complete response letter from the US Food and Drug Administration denying its application for a jet lag disorder indication for Hetlioz, Vanda Pharmaceuticals, Inc. filed suit to obtain the agency’s review documents.

The company says the FDA’s medical and statistical reviews are usually the most critical evidence used by the agency to determine what action to take on a new drug application or supplemental drug application. “Without seeing the specific information, Vanda cannot understand whether and how to adapt its development program,” the 6 April

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