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Elite Pharmaceuticals secures FDA approval for generic Sabril

Vigabatrin is an antiepileptic drug indicated for refractory complex partial seizures and used as an adjunctive therapy in patients who have inadequately responded to several alternative treatments.
Sandra Levy
Levy

Elite Pharmaceuticals, a specialty pharmaceutical company developing niche generic products, has received clearance from the Food and Drug Administration for a generic version of Sabril (vigabatrin) 500 mg powder for solution packet.

[Read more: Elite, Prasco launch loxapine capsules]

Vigabatrin is an antiepileptic drug indicated for refractory complex partial seizures and used as an adjunctive therapy in patients who have inadequately responded to several alternative treatments.

[Read more: Zydus obtains FDA nod for generic Sabril]

Lannett has an exclusive license to market and distribute the product in the United States and territories. Elite will exclusively manufacture and package the product for sale for an agreed-upon transfer price. The companies will share in product net profits, according to Elite.

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