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VANDA PHARMACEUTICALS INC. v. FOOD AND DRUG ADMINISTRATION et al
Case Number:
1:23-cv-02812
Court:
Nature of Suit:
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
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July 11, 2024
DC Judge Questions Pharma Co.'s Generic Harm In FDA Spat
A D.C. federal judge on Thursday seemed skeptical about Vanda Pharmaceuticals' claims that waiting for the U.S. Food and Drug Administration to review its challenge to the agency's approval of a generic challenger to its sleep medication would seriously jeopardize the company's future.
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September 26, 2023
Vanda Challenges FDA's Clearance Of Generic Sleep Drug
Vanda Pharmaceuticals Inc. has hit federal drug regulators with a lawsuit claiming they wrongly gave the green light to an application on a generic version of the company's brand-name sleep drug Hetlioz, saying the government "turned a blind eye to" problems in the generic drug's studies.