Lupin bags USFDA nod for Allopurinol Tablets

Mumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Allopurinol Tablets USP, 100 mg and 300 mg to market a generic equivalent to the reference listed drug (RLD), Zyloprim Tablets, 100 mg, and 300 mg, of Casper Pharma, LLC.

The product will be manufactured at Lupin’s Pithampur facility in India.

Allopurinol Tablets USP, 100 mg and 300 mg are indicated for the management of:

• Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy)

• Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels

• Adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes

Allopurinol Tablets (RLD Zyloprim) had estimated annual sales of USD 88.1 million in the U.S. (IQVIA MAT October 2023).

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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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.

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