By: IPP Bureau
Last updated : December 17, 2023 8:51 am
The product will be manufactured at Lupin's Pithampur facility in India
Lupin Limited (Lupin) has received approval from the United States Food and Drug Administration (USFDA) 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. 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 US$ 88.1 million in the US (IQVIA MAT October 2023).