The U.S. Food and Drug Administration approved a generic version of H. Lundbeck A/S's Sabril — the first copy of the epilepsy drug to ever be approved in the U.S.
Israel's Teva Pharmaceutical Industries Ltd. will market the medicine, which is also known as vigabatrin, to treat complex partial seizures, or focal seizures, in epilepsy patients 10 years and older who have had inadequate responses to several alternative treatments. Complex partial seizures last between 30 and 90 seconds and can be followed by a period of disorientation, confusion and fatigue.
U.S. FDA Commissioner Scott Gottlieb, in a news release, said the generic's approval shows that the regulator has an open pathway to approving generic drugs which compete with medicines that face little or no competition. The regulator broke records in 2018 for approvals of generic drugs and biosimilars, or lower-cost versions of biologic therapies.
"We're especially focused on new policies aimed at making the generic review process more predictable, efficient and lower cost so we can entice more generic firms to enter this space, and help facilitate more generic drug launches after generic approvals," Gottlieb said.