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Pharmaceuticals / Inspections and Audits

FDA Cites Vanda for Misleading Website

Nov. 8, 2018
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In a rare warning letter from the FDA’s Office of Prescription Drug Promotion (OPDP), Vanda Pharmaceuticals was cited for failing to include any risk information on the product page of its website.

The OPDP found the biopharma company’s product page was false and misleading because it didn’t describe any of the risks associated with its schizophrenia treatments Fanapt (iloperidone) and Hetlioz (tasimelteon).

“This violation is concerning from a public health perspective because it creates a misleading impression about the safety of Fanapt and Hetlioz,” the OPDP said.

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