Lupin gets USFDA nod for generic hypertension drug

The drug major on Monday (25 July 2022) announced that it received approval from the US drug regulator for Azilsartan Medoxomil tablets.

Lupin has received approval from the United States Food and Drug Administration (US FDA) 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 Azurity Pharmaceuticals, Inc. The drug is primarily used to reduce high blood pressure.

The product will be manufactured at Lupin's facility in Nagpur, India.

Azilsartan Medoxomil tablets (RLD Edarbi) had estimated annual sales of $101 million in the U.S. (IQVIA MAT March 2022).

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

The pharma giant reported a consolidated net loss of Rs 518 crore in Q4 FY22 as against a net profit of Rs 460.4 crore in Q4 FY21. Income from operations rose by 2.8% year on year to Rs 3,864.5 crore during the quarter.

Shares of Lupin fell 1.01% to settle at Rs 632.80 on Monday.

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