Lupin bags USFDA nod for generic equivalent of Edarbi Tablets
Mumbai: Global pharma major Lupin Limited has announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Azilsartan Medoxomil Tablets, 40 mg, and 80 mg.
The product is a generic equivalent of Edarbi Tablets, 40 mg, and 80 mg, of Arbor Pharmaceuticals, LW.
This product will be manufactured at Lupin's Nagpur facility in India.
Azilsartan Medoxomil Tablets (RLD: Edarbi Tablets) had estimated annual sales of USD 103.4 million in the U.S. (IQVIA MAT September 2021).
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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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.
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