Regulatory Focus™ > News Articles > 2019 > 1 > FDA Approves First Generic Version of Lundbeck’s Sabril

FDA Approves First Generic Version of Lundbeck’s Sabril

Posted 16 January 2019 | By Zachary Brennan 

FDA Approves First Generic Version of Lundbeck’s Sabril

The US Food and Drug Administration (FDA) on Wednesday approved Teva Pharmaceuticals’ first generic tablet version of Lundbeck’s seizure medicine Sabril (vigabtrin).

Vigabatrin tablets are FDA-approved for the treatment of refractory complex partial seizures (CPS) as an adjunctive therapy in patients 10 years of age and older who have responded inadequately to several alternative treatments. The vigabatrin powder market had US sales of approximately $333 million for the 12 months ending 31 December 2017, according to IQVIA.

"We know there has been past interest in developing a generic alternative to this product. Earlier this year, we also highlighted this drug, along with many others, on a list of off-patent, off-exclusivity branded drugs without approved generics, to clarify that there were no patents or exclusivities that should impede its approval. Today's action demonstrates that there is an open pathway to approving products like this one,” FDA Commissioner Scott Gottlieb said. 

The approval comes as last year FDA began publishing a list of inquiries from generic drug developers seeking FDA’s assistance in obtaining samples from brand companies, which included Sabril. Four inquiries were received by FDA after companies tried to work with Lundbeck.

Some of those seeking assistance noted that these brand-name drug companies were blocking access to samples of their brand products when the brand products were subject to limited distribution programs, including risk evaluation and mitigation strategies (REMS).

In June 2016, FDA announced the approval of a supplemental New Drug Application (sNDA) modifying the REMS for Sabril. FDA determined that, although the risk of vision loss with Sabril still exists, the REMS should be modified to remove certain elements. Teva’s generic vigabatrin tablets are now part of a single shared-system Risk Evaluation and Mitigation Strategy program with other drug products containing vigabatrin to ensure safe use of the product.

Meanwhile, FDA said it has continued to emphasize that even in the case of limited distribution programs, there should be a path forward for generic drug development. And FDA has published a list of off-patent, off-exclusivity branded drugs without approved generics, which the agency said it will refine and update periodically to ensure continued transparency around drug categories where increased competition has the potential to provide significant benefit to patients.

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