United States: FDA Denies Vanda's Citizen Petitions Regarding The Need For Braille Labeling For Tasimelteon Generics - Hyman, Phelps, & McNamara, P.C.

United States: FDA Denies Vanda's Citizen Petitions Regarding The Need For Braille Labeling For Tasimelteon Generics - Hyman, Phelps, & McNamara, P.C.

Mondaq

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In January 2023, Vanda Pharmaceuticals, Inc. (Vanda) submitted two interesting and substantially similar citizen petitions (Docket Nos. FDA-2023-P-0313 and FDA-2023-P-0344) regarding its product Hetlioz (tasimelteon).

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