Lupin receives USFDA nod on Azilsartan Medoxomil tablets

Lupin intimated that it has secured a tentative approval from the US-based drug regulator, United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Azilsartan Medoxomil tablets.

The United States Food and Drug Administration (USFDA) has given approval for its Abbreviated New Drug Application (ANDA), Azilsartan Medoxomil tablets (in the strengths of 40 mg and 80 mg) to market a generic equivalent of Edarbi tablets (in the strengths of 40 mg and 80 mg) of Arbor Pharmaceuticals, LW.

The product will be manufactured at Lupin's Nagpur facility (Maharashtra) in India. As per IQVIA MAT September 2021 data, Azilsartan Medoxomil tablets (RLD: Edarbi tablets) had estimated annual sales of $103.4 million in the U.S.

The company reported a consolidated net loss of Rs 2,094.87 crore in Q2 FY22 as against net profit of Rs 213.51 crore in Q2 FY21. On a consolidated basis, net sales rose 5.9% to Rs 4,003.42 crore in Q2 FY22 over Q2 FY21.

Shares of Lupin shed 0.35% to Rs 909.05 on BSE. Lupin is an innovation-led 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.

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