March 28, 2023
The U.S. Food and Drug Administration did not satisfy its obligation to show "foreseeable harm" in releasing internal reviews to explain its denial of a label expansion for a Vanda Pharmaceuticals sleep disorder drug, a D.C. federal judge ruled Monday, in a Freedom of Information Act win for the company.
April 07, 2022
Vanda Pharmaceuticals Inc. has hit the U.S. Food and Drug Administration with a lawsuit asking a Washington, D.C., federal judge to force the agency to explain why it denied a label expansion on the company's sleep-wake disorder drug Hetlioz.