February 13, 2025
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.
February 01, 2023
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.