Lupin receives approval from U.S. FDA for Allopurinol Tablets

Global pharma major Lupin Limited (Lupin) 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).

Shares of Lupin Limited was last trading in BSE at Rs. 1245.65 as compared to the previous close of Rs. 1254.85. The total number of shares traded during the day was 16320 in over 989 trades.

The stock hit an intraday high of Rs. 1265.00 and intraday low of 1243.35. The net turnover during the day was Rs. 20458924.00.

Source : Equity Bulls

Keywords

Lupin Approval USFDA ANDA AllopurinolTablets