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Vanda Pharmaceuticals (NASDAQ:VNDA) has received a favorable ruling from the US Court of Federal Claims in Washington, D.C., allowing the company to advance its legal challenge against the FDA concerning the handling of critical information linked to Vanda’s drugs Hetlioz and Fanapt.
The court, on Jan. 18, rejected the US government’s attempt to dismiss the case, thus paving the way for the lawsuit to proceed. In light of this development, Vanda stated its intention to pursue discovery to bolster its assertions against the FDA.
Vanda initiated the lawsuit against the FDA in May, alleging the agency’s “uncompensated taking and misuse of Vanda’s trade secrets and confidential information.” The company contends that the FDA inappropriately disclosed confidential information about the drugs to generic drug manufacturers during their generic drug application reviews.
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