Lupin gets US FDA approval for bromfenac ophthalmic solution, 0.07% and tentative nod for canagliflozin tablets

Global pharma major Lupin Limited (Lupin) has received the United States Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application for bromfenac ophthalmic solution, 0.07%, to market a generic equivalent of Prolensa ophthalmic solution, 0.07%, of Bausch & Lomb Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180-day exclusivity.

Bromfenac ophthalmic solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

The company also received tentative approval from US FDA for its ANDA 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.

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: as an adjunct to diet and exercise to improve glycaemic 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.

Both the products will be manufactured at Lupin’s Pithampur facility in India.

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