Global pharma major Lupin Limited (Lupin) on Friday announced that it 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 bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zyloprim Tablets, 100 mg, and 300 mg, of Casper Pharma, LLC.
It also received U.S. FDA tentative approval for Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg to market a generic equivalent of Januvia Tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharp and Dohme Corp. (Merck), the company announced through an exchange filing.
These products will be manufactured at Lupin’s Pithampur facility in India.
About Allopurinol Tablets
Allopurinol Tablets USP, 100 mg and 300 mg are indicated for the management of:
i) Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
ii) 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.
iii) 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
About Sitagliptin Tablets
Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Estimated annual sales
Allopurinol Tablets had estimated annual sales of USD 88.1 million in the U.S. (IQVIA MAT October 2023) and Sitagliptin Tablets had estimated annual sales of USD 5789.3 million in the U.S. (IQVIA MAT October 2023).
Lupin Limited shares
The shares of Lupin Limited on Friday at 3:30 pm IST were at Rs 1,250, down by 0.51 percent.
