Lupin gets US FDA nod to market generic drug
The product is the generic equivalent of Lundbeck Pharmaceuticals' Sabril for oral solution
Lupin recently said it has received approval from the US health regulator to market its anti-epilepsy drug Vigabatrin for Oral Solution in the American market.
The company has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Vigabatrin for Oral Solution USP (500 mg), Lupin said in a statement.
The product is the generic equivalent of Lundbeck Pharmaceuticals’ Sabril for Oral Solution.
The product will be manufactured at Lupin’s manufacturing facility in Goa, it added.
As per IQVIA MAT December 2021 data, Vigabatrin for Oral Solution USP (500 mg) had estimated annual sales of $275 million (around Rs 2,100 crores) in the US.
Edits by EP News Bureau
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