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The Lupin stock surged by 2.86 per cent on the BSE, trading at ₹1,281.30 as of 10:20 am on Monday.
The USFDA recently provided ANDA (Abbreviated New Drug Application) approval for its 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.
The tablet had estimated annual sales of $88.1 million in the US (IQVIA MAT October 2023).
The tablets, according to Lupin’s regulatory filing, are 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 paediatric patients with leukemia, lymphoma and solid tumor malignancies, who are receiving cancer therapy, which causes elevation of serum and urinary uric acid levels; and
- 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
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