Trade Secrets In Court: Are Dissolution Specifications That FDA Gave Vanda Proprietary?
Court of Federal Claims lets Vanda’s suit against the agency go forward but notes a ruling for the company could undermine FDA’s ability to provide assistance to other brand name and generic manufacturers.
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Serial litigator Vanda Pharmaceuticals has followed through on its pledge to take its patent-infringement loss to Teva and Apotex over its Hetlioz sleep-disorder brand all the way to the US Supreme Court.
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.
A provision in the pending legislation on PBMs that would allow the US FDA to provide qualitative and quantitative information to ANDA sponsors about reference product's inactive ingredients could save hundreds of millions in spending.