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VANDA PHARMACEUTICALS, INC. v. FOOD AND DRUG ADMINISTRATION et al
Case Number:
1:23-cv-00280
Court:
Nature of Suit:
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
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February 13, 2025
DC Judge Affirms Approval Of Teva's Generic Sleep Drug
A D.C. federal judge upheld the U.S. Food and Drug Administration's approval of Teva's generic version of Vanda's sleep-walking treatment tasimelteon, ruling Thursday that omitting Braille on the labeling is permissible as it would be "aberrant" to allow safe variations in a drug's substance but not for labeling.
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February 01, 2023
Vanda Sues FDA Over Approval Of Teva Generic Sleep Drug
Vanda Pharmaceuticals Inc. has brought a suit against the U.S. Food and Drug Administration and U.S. Department of Health and Human Services, saying the FDA must undo its approval of a generic version of Vanda's sleep-wake disorder drug made by Teva Pharmaceuticals USA Inc. because it does not include braille on the label.