FDA rejects new drug application for internasal carbetocin to treat Prader-Willi syndrome
The FDA’s Division of Psychiatry has rejected a new drug application for treating hyperphagia, anxiousness and distress associated with Prader-Willi syndrome, according to a press release.As Healio previously reported, the FDA granted priority review for LV-101 (intranasal carbetocin, Levo Therapeutics) in July 2021. In a complete response letter, the FDA determined the therapy was safe and
Source: healio.com