Lupin Get US FDA Nod for Generic Invokamet XR Tablets

Lupin Limited, a global pharmaceutical company, has received tentative approval from the FDA for its Abbreviated New Drug Application for canagliflozin and metformin hydrochloride extended-release tablets. These tablets are the generic equivalent of Janssen Pharmaceuticals' Invokamet XR tablets in various strengths. The production of this product will take place at Lupin's facility in Pithampur, India. Canagliflozin and metformin hydrochloride extended-release tablets are prescribed alongside a healthy diet and exercise regimen to enhance glycemic control in adults diagnosed with type 2 diabetes mellitus.

In adults with type 2 diabetes mellitus and existing cardiovascular disease , Canagliflozin is prescribed as a means to lessen the likelihood of major adverse cardiovascular events, which include cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. In adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day, Canagliflozin is prescribed to decrease the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure. According to IQVIA MAT July 2023, the US sales of Invokamet XR, a combination of canagliflozin and metformin hydrochloride extended-release tablets, reached approximately USD 28 million annually. Located in Mumbai, India, Lupin stands as a forward-thinking multinational pharmaceutical company driven by innovation. The company engages in the development and commercialization of various branded and generic formulations, as well as biotechnology products and APIs. It operates in more than 100 markets spanning the US, India, South Africa, and multiple regions including Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.