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FDA points to deficiencies in Vanda's latest drug application

Staff
FDA points to deficiencies in Vanda's latest drug application

Vanda Pharmaceuticals Inc. disclosed a note from federal regulators that pointed to deficiencies in its latest application for approval for a jet lag disorder treatment — but said the regulators didn't offer any more specifics. The D.C. biotech had applied for Food and Drug Administration approval to expand the label for its existing drug, Hetlioz, to be able to treat jet lag disorder. The company has been selling Hetlioz on the market since it was approved in 2014 to treat non-24-hour sleep-wake disorder, and it has fast become the company's top-selling product.