US FDA focuses on generics and approves first for Sabril
The US Food and Drug Administration (FDA) has expressed its efforts to carve a path for generic drug development, even in the case of limited distribution programs for brand name drugs, to ensure transparency around drug categories where competition has the potential to provide benefit to patients.
Scott Gottlieb said in a statement that the agency’s resolve to prioritize the approval of generic drugs to compete with medicines that “face little or no competition” is part of its efforts to support access and reduce drug costs.
“WThe availability of high-quality generic alternatives of critically important medicines, once the period of patent protection or exclusivity has ended on the brand drug, helps advance access and saves consumers billions of dollars each year,” said Gottlieb.
In 2018, the FDA started to publish its list of enquiries from generic drug developers seeking assistance in obtaining samples from brand companies, including that of Sabril (vigabatrin).
The agency noted that brand companies were potentially preventing generic developers from having access to samples when the brand products were subject to limited distribution programs.
“Today’s action [to approve generic vigabatrin tablets] demonstrates that there is an open pathway to approving products like this one. 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 further explained.
Generic vigabatrin tablets, developed by Teva, are indicated for the treatment of partial seizures.
Safety and efficacy of generics
To achieve generic approval the FDA requires data that demonstrates that generic drugs meet the approval standards, as well as being as safe and effective as their brand name counterparts.
Teva’s generic vigabatrin tablets is part of a single shared-system risk evaluation and mitigation strategy program with other drug products that contain vigabatrin to safeguard use of the product.
According to the FDA, both brand and generic drug makers are required to develop a single shared-system risk and evaluation mitigation program when a generic drug seeks approval.