Absence Of Braille In Generic Hetlioz Label Merits Its Withdrawal, Vanda Lawsuit Argues
Executive Summary
Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.
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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.
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.
Vanda’s Fourth Suit Against US FDA Claims Agency Shared Its Manufacturing Trade Secrets
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