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Lupin Shares Gain 3% on Receiving Approval From USFDA for Gout and Diabetes Drugs

Lupin
Lupin will receive an upfront licence fee along with royalties on net sales.

Shares of Lupin were trading in the green and 3% higher on 18 December after the company announced receiving approval from the USFDA (US Food and Drug Administration) for its gout and diabetes drugs.

In its regulatory filing, the company said, “The company has received the approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) 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.”

Allopurinol Tablets USP, 100 mg and 300 mg, are used to manage adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).

The drug is used on adult and pediatric patients who have leukaemia, lymphoma and solid tumour malignancies or are receiving cancer therapy, which causes elevations of serum and urinary uric acid levels.

Allopurinol is used to treat adult patients with recurrent recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients.

The company said that the drugs will be manufactured at its Pithampur facility in India.

At 12:29 pm, shares of Lupin were trading 2.12% higher at Rs 1,272.55 on NSE.

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