Vanda Warning Letter From US FDA Leaves Firm "Puzzled"

CEO Polymeropoulos tells the Pink Sheet that both subject and severity of letter regarding description of products on corporate website seem like an overreaction by the agency.

Is the difference between these two pages worth a warning letter?

The US FDA's warning letter to Vanda Pharmaceuticals Inc. seems relatively straightforward – the agency says the company included indications but not safety information when it listed its marketed products on its website – but the company says the correspondence actually raises a host of questions.

"We understand the words of the letter. What we are puzzled by is the reasoning for this action," Vanda CEO Mihael Polymeropoulos told the Pink Sheet in an interview. The confusion "comes in two flavors," he said

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