Lupin receives USFDA approval to market generic drug

Lupin on Friday announced that it received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA), Vigabatrin for Oral Solution.

Vigabatrin is a market a generic equivalent of Sabril of Lundbeck Pharmaceuticals, LLC. The product will be manufactured at Lupin's facility in Goa, India.

Vigabatrin is an analog of gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the central nervous system, used in the treatment of refractory seizures and infantile spasms.

According to IQVIA, Vigabatrin for Oral Solution USP had estimated annual sales of $275 million in the U.S in 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.

Lupin'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.

Shares of Lupin ended 1.18% higher at Rs 748.15 on Friday.

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