First generic tablet version of popular epilepsy drug approved

FDA cleared the first generic tablet version of a top-selling epilepsy drug.

FDA approved generic vigabatrin of Sabril (Lundbeck) 500 mg for treating complex partial seizures as an adjunctive therapy in patients 10 years and older who have responded inadequately to several alternative treatments.

Teva Pharmaceuticals was approved to market generic tablet versions of Sabril, which realized a revenue drop of 16% in 2018, according to Lundbeck.

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Amneal Pharmacetuicals began marketing a generic oral version of Sabril last year, and said it filed an ANDA with the FDA for the tablet form of vigabatrin.    

"Prioritizing the approval of generic drugs to compete with medicines that face little or no competition is a key part of our efforts to support access and reduce drug costs to patients. The 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 FDA Commissioner Scott Gottlieb, MD, in a statement from the agency.

Labeling for vigabatrin tablets includes a Boxed Warning for permanent vision loss. Teva’s generic vigabatrin tablets is part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program with other drug products containing vigabatrin to ensure safe use of the product.

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Last year, FDA began to publish a list of inquiries from generic drug developers seeking FDA’s assistance in obtaining samples from brand companies, which included Sabril, noting the pharma makers were potentially blocking access to the samples of their brand products when the drugs are subject to limited distribution programs, including REMS, FDA said in the statement.

“The FDA has continued to emphasize that even in the case of limited distribution programs, there should be a path forward for generic drug development. Additionally, the FDA’s list of off-patent, off-exclusivity branded drugs without approved generics is an effort the FDA began in 2017 and will continue to refine and update periodically to ensure continued transparency around drug categories where increased competition has the potential to provide significant benefit to patients,” the agency said.

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