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![.. Lupin secures US FDA approval for generic allopurinol tablets](https://cdn.shortpixel.ai/stsp/to_webp,q_lossy,ret_img/https://images.moneycontrol.com/static-mcnews/2023/08/Lupin7-770x433.jpg?impolicy=website&width=770&height=431)
The newly approved product will be manufactured at Lupin’s facility in Pithampur, India
Indian pharma major Lupin Limited said it, has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Allopurinol Tablets USP, 100 mg, and 300 mg.
The approval allows Lupin to market a generic equivalent to the reference listed drug (RLD), Zyloprim Tablets, 100 mg, and 300 mg, originally developed by Casper Pharma, LLC.
The newly approved product will be manufactured at Lupin’s facility in Pithampur, India, showcasing the company’s commitment to delivering high-quality pharmaceuticals on a global scale.
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 change
The approval from the US FDA marks a significant milestone for Lupin Limited, reinforcing its commitment to advancing the pharmaceutical industry’s generic sector. This achievement not only enhances Lupin’s global footprint but also underlines the company’s dedication to delivering affordable and high-quality healthcare solutions to a diverse range of patients worldwide.
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