Teva gets FDA green light for first generic Sabril

1/16/2019
Teva’s latest approval marks the first for a generic Sabril, the brand-name complex partial seizure treatment made by Lundbeck.

The Food and Drug Administration approved Teva’s vigabatrin 500 mg tablets to treat complex partial seizures. The generic Sabril is indicated as adjunctive therapy in patients age 10 years old and older who have responded inadequately to several alternative treatments

"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," FDA commissioner Scott Gottlieb said. "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."
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