Lupin Gains Tentative FDA Approval For Generic Canagliflozin & Metformin Tablets
Lupin received tentative approval from the United States Food and Drug Administration (U.S. 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, the company said in a press statement on Tuesday.
This product will be manufactured at Lupin’s Pithampur facility in India, the company stated.
Canagliflozin and Metformin Hydrochloride Extended-Release Tablets serve as an adjunct to diet and exercise, primarily aimed at enhancing glycemic control in adults diagnosed with type 2 diabetes mellitus. Additionally, Canagliflozin plays a crucial role in reducing the risk of major adverse cardiovascular events, which encompasses cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, in adults suffering from type 2 diabetes mellitus with established cardiovascular disease.
Furthermore, it also holds an indication for lowering the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalisation due to heart failure in adults afflicted with type 2 diabetes mellitus and diabetic nephropathy characterised by albuminuria greater than 300 mg/day.
Canagliflozin and Metformin Hydrochloride Extended-Release Tablets (RLD Invokamet XR) had estimated annual sales of USD 28 million in the U.S. according to IQVIA MAT July 2023, the company's statement read.
