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Mealeys

MLex

April 06, 2022

VANDA PHARMACEUTICALS, INC. v. FOOD AND DRUG ADMINISTRATION

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Reflects complaints, answers, motions, orders and trial notes entered from Jan. 1, 2011.
Additional or older documents may be available in Pacer.

Coverage

  1. March 28, 2023

    Vanda Can See FDA Docs On Drug Label Denial, Judge Says

    The U.S. Food and Drug Administration did not satisfy its obligation to show "foreseeable harm" in releasing internal reviews to explain its denial of a label expansion for a Vanda Pharmaceuticals sleep disorder drug, a D.C. federal judge ruled Monday, in a Freedom of Information Act win for the company.

1 other articles on this case. View all »

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