Lupin receives US FDA tentative approval for generic Invokamet XR tablets

Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for canagliflozin and metformin hydrochloride extended-release tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg to market a generic equivalent of Invokamet XR tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg, of Janssen Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

Canagliflozin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Canagliflozin is indicated to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

 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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