Lupin receives US-FDA approval for allopurinol tablets and tentative approval for sitagliptin tablets

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (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 company also received tentative US FDA approval for its ANDA, 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).

According to a company press release, both the products will be manufactured at its 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 paediatric patients with leukaemia, lymphoma and solid tumour 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.

Sitagliptin tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus. Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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