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Absence Of Braille In Generic Hetlioz Label Merits Its Withdrawal, Vanda Lawsuit Argues

 
• By Brenda Sandburg

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.

Braille
Vanda contends labeling of generic Hetlioz should include braille lettering. • Source: Shutterstock

Vanda Pharmaceuticals, Inc.’s novel legal battles against the US Food and Drug Administration continue as the company claims the agency should not have approved Teva Pharmaceuticals USA Inc.’s generic version of its sleep disorder drug Hetlioz (tasimelteon) because the product label lacks braille lettering.

“Because tasimelteon is indicated to treat a disorder that occurs with substantial prevalence in the blind population, FDA’s approval of Teva’s ANDA despite Teva’s failure to include Braille lettering on its label risks substantial public-health harms

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