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Vanda Lodges ANDA Trade Secret Case Against US Government

Originator Makes Claims Over Its Fanapt And Hetlioz Brands

 
• By Dean Rudge

US originator Vanda Pharmaceutical namechecked several generics manufacturers, including Teva, as part of its trade secrets and confidential information lawsuit against the US government.

FDA changing climate
• Source: photo illustration

The US Food and Drug Administration misused Vanda Pharmaceutical’s trade secrets and confidential information when it “improperly provided confidential details” from Vanda’s drug master files for its key brands, Hetlioz (tasimelteon) and Fanapt (iloperidone), to generics manufacturers during review of their abbreviated new drug applications, the originator has alleged in a lawsuit filed against the US federal government.

At the crux of Vanda’s complaint are the proposed “dissolution specifications,” indicating how much of the label-listed active ingredient must dissolve by a specified point after administration for the

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