Teva, FDA Score Win in Fight Over Approval of Generic Sleep Drug

Vanda Pharmaceuticals Inc. failed to convince a federal judge that the FDA unlawfully approved a generic version of its drug used to treat non-24-hour sleep-wake disorder.

Judge Tanya S. Chutkan of the US District Court for the District of Columbia denied on Thursday Vanda’s challenge that sought to block the Food and Drug Administration’s approval of Teva Pharmaceuticals’s abbreviated new drug application (ANDA) for its generic tasimelteon. Vanda alleged Teva’s generic label violated the statutory same-label requirement and that the changes unlawfully altered the drug’s conditions of use.

“The FDA did not unlawfully approve Teva’s ANDA, which proposed a ...