Generic Hetlioz Does Not Require Braille Labeling, FDA Tells Vanda

FDA says Teva and Apotex’s generic products do not violate the ‘same labeling’ requirement because they were produced by different manufacturers and that braille is not necessary for safe and effective use of tasimelteon products. Vanda's generic labeling suit against the FDA remains pending.

Braille label
The FDA says braille is not required in labeling for generic versions of the sleep disorder drug Hetlioz. • Source: Shutterstock

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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