Sefelsa gabapentin regulatory update

FDA's Reproductive Health Drugs Advisory Committee voted that the overall benefit/risk profiles of 2 compounds do not support approval to treat moderate to severe vasomotor symptoms (VMS) associated with menopause. The committee voted 12-2 against Sefelsa gabapentin from Depomed. Depomed said it will cease all spending related to Sefelsa "until we believe there is a positive direction" for the product. The extended-release tablet formulation of gabapentin that uses Depomed's Acuform delivery technology has a May 31 PDUFA date. ...