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Vanda’s Fourth Suit Against US FDA Claims Agency Shared Its Manufacturing Trade Secrets

 
• By Brenda Sandburg

Vanda is fighting FDA’s rejection of jet lag indication for Hetlioz as it faces generic competition for sleep-wake disorder treatment. Federal Circuit finds four Hetlioz patents invalid.

Confidential
Vanda lawsuit claims FDA shared its confidential information with competitors • Source: Shutterstock

Vanda Pharmaceuticals, Inc. is once again pursuing novel litigation against the US Food and Drug Administration, this time claiming the agency shared confidential information in its new drug applications with generic competitors.

In a complaint filed earlier this month in the US Court of Federal Claims, Vanda alleges that the agency disclosed trade secret information about its manufacturing processes for Fanapt...

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