The US Food and Drug Administration rejected Vanda Pharmaceuticals, Inc.’s requests that it revoke approval of Teva Pharmaceuticals USA Inc.’s and Apotex Inc. ’s generic versions of Hetlioz (tasimelteon) because their labels do not have braille lettering, saying a generic’s labeling can differ from the reference listed drug when the products are produced or distributed by different manufacturers.
The products are indicated for the treatment of non-24-hour sleep wake disorder, an inability in completely blind people to synchronize...
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