Lupin type 2 diabetes drug Canagliflozin bags USFDA tentative approval
Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Canagliflozin Tablets, 100 mg and 300 mg, to market a generic equivalent of Invokana Tablets, 100 mg and 300 mg, of Janssen Pharmaceuticals, Inc.
This product will be manufactured at Lupin’s Pithampur facility in India.
Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease
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
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