Generics
Amneal unveils generic Sabril for Oral Solution, USP
3 May 2018 -

Generics pharmaceutical company Amneal Pharmaceuticals revealed on Wednesday the availability of vigabatrin for oral solution USP.

The company added vigabatrin for oral solution USP is the generic equivalent for Sabril. This is the second generic vigabatrin product currently on the market. The Amneal generic product received US FDA approval under a Risk Evaluation and Mitigation Strategy (REMS): the Vigabatrin REMS programme.

Each carton contains 50, 500 mg packets of vigabatrin. The finished dosage form is manufactured in the US, stated the company.

In conjunction, the company has filed an ANDA with US FDA for the tablet form of vigabatrin.

Annually, the US sales of vigabatrin for oral solution (brand and generic) were USD318m, according to March 2018 IQVIA market data, concluded the company.

Sabril is indicated as adjunctive therapy for patients ten years of age and older with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril is indicated as monotherapy for pediatric patients one month to two years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss, concluded the company.

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