Generic Hetlioz Does Not Require Braille Labeling, FDA Tells Vanda

 
• By Brenda Sandburg

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

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