Lupin Receives Tentative Approval from U.S. FDA for Canagliflozin Tablets

Global pharma major Lupin Limited (Lupin) today 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

Canagliflozin Tablets (RLD Invokana®) had estimated annual sales of USD 561 million in the U.S. (IQVIA MAT September 2023).

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