Lupin Limited (Lupin) on March 11, 2022 announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Vigabatrin for Oral Solution USP, 500 mg.
Vigabatrin is a generic equivalent of Sabril® for Oral Solution, 500 mg of Lundbeck Pharmaceuticals, LLC.
The product will be manufactured at Lupin’s facility in Goa, India.
Vigabatrin for Oral Solution USP, 500 mg (RLD Sabril®) had estimated annual sales of USD 275 million in the U.S. (IQVIA MAT December 2021).
Vigabatrin for Oral Solution USP, 500 mg (RLD Sabril®) had estimated annual sales of USD 275 million in the U.S. (IQVIA MAT December 2021).
About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue in research and development in FY21.
