Lupin gets USFDA approval for generic antispasmodic drug

The global pharma major announced that it received approval from the US drug regulator for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate extended-release tablets, 4 mg and 8 mg.

The drug is a generic equivalent of Toviaz extended-release tablets, 4 mg and 8 mg, of Pfizer Inc.

This medication is used to treat certain bladder problems (overactive bladder, neurogenic detrusor overactivity). This medication belongs to the class of drugs known as antispasmodics.

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

Fesoterodine Fumarate extended-release tablets, 4 mg and 8 mg, (RLD Toviaz) had estimated annual sales of $177 million in the US (IQVIA MAT September 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 U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

On consolidated basis, Lupin reported net profit of Rs 129.73 crore in Q2 FY23 as against net loss of Rs 2,098.04 crore in Q2 FY22. Revenue from operations rose 2.2% to Rs 4,091.16 crore in Q2 FY23 as against Rs 4,003.42 crore in Q2 FY22.

Shares of Lupin fell 0.60% to Rs 738.45 on Friday, 6 January 2023.

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