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Vanda Launches Barrage Of Suits Against FDA Seeking To Retain Hetlioz Market

 
• By Brenda Sandburg

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

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Vanda's lawsuits against FDA seek transparcncy and accountability from the agency, CEO says. • Source: Shutterstock

Vanda Pharmaceuticals, Inc. has continuously clashed with the US Food and Drug Administration and turned to the courts to try to compel the agency to take action in its favor in long-simmering battles across multiple fronts.

The Washington, DC-based company has filed 17 suits against the FDA and one against the US government. Most of the cases have involved its non-24-hour sleep-wake disorder drug Hetlioz (tasimelteon) and Vanda’s efforts to stave off generic competition and expand the indication for the drug

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