Lupin shares gain 2.5% on US FDA nod to gout, diabetes drugs

The products will be manufactured at company’s Pithampur facility in India.

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Shares of Lupin gained 2.5 percent in the early trade on December 18 after its gout and diabetes drugs received the USFDA approval.

At 9:27am, Lupin was quoting at Rs 1,276.60, up Rs 30.95, or 2.48 percent, on the BSE.

“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,” company said in its release.

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).

It is used on 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 are also treated by Allopurinol.

In an another development, the company said that it has received the tentative approval from the USFDA for its ANDA 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).

Theseproducts will be manufactured at company’s Pithampur facility in India.

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

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Earlier in December, the company announced the launch of its Regional Reference Laboratory in Chennai, Tamil Nadu.

Lupin also received the USFDA nod for Varenicline Tablets, 0.5 mg and 1 mg, indicated for use as an aid to smoking cessation treatment.