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VANDA PHARMACEUTICALS, INC. v. FOOD AND DRUG ADMINISTRATION
Case Number:
1:22-cv-00938
Court:
Nature of Suit:
Administrative Procedure Act/Review or Appeal of Agency Decision
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
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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.
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April 07, 2022
Vanda Wants FDA Info Behind Label Expansion Denial
Vanda Pharmaceuticals Inc. has hit the U.S. Food and Drug Administration with a lawsuit asking a Washington, D.C., federal judge to force the agency to explain why it denied a label expansion on the company's sleep-wake disorder drug Hetlioz.