Lupin gets US FDA nod for epilepsy drug

Lupin said that it has received approval from the United States Food and Drug Administration (FDA) for Vigabatrin for oral solution USP.

The approved abbreviated new drug application (ANDA) is a generic equivalent of Sabril for oral solution of Lundbeck Pharmaceuticals, LLC.

The product will be manufactured at Lupin's facility in Goa, India, the drug maker said.

Vigabatrin is a medication used to treat epilepsy.

Vigabatrin for oral solution USP had estimated annual sales of $275 million in the U.S. (IQVIA MAT December 2021).

Lupin is a transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The company's consolidated net profit jumped 24.47% to Rs 545.52 crore on a 3.57% rise in total revenue from operations to Rs 4160.93 crore in Q3 FY22 over Q3 FY21.

The scrip was currently trading 0.67% higher at Rs 753.20 on the BSE.

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