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Lupin obtains FDA OK for generic Bromfenac, tentative nod for generic Invokana

Generic Bromfenac Ophthalmic Solution is indicated for the treatment of post operative inflammation and reduction of ocular pain in patients who have under gone cataract surgery.
Sandra Levy
Senior Editor
Levy

Lupin has received the FDA’s permission for Bromfenac Ophthalmic Solution, 0.07%, which is a generic of Bausch & Lomb’s Prolensa. 

Lupin is the exclusive first-to-file for this product and is eligible for 180-day exclusivity. The product will be manufactured at Lupin’s Pithampur facility in India.

Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of post-operative inflammation and reduction of ocular pain in patients who have under gone cataract surgery.

[Read more: Lupin receives FDA OK for generic Banzel]

Bromfenac Ophthalmic Solution (Prolensa) had a market value of roughly $185 million, per IQVIA September 2023 data.

Lupin has received tentative approval from the FDA for Canagliflozin tablets, 100 mg and 300 mg, which is the generic of Janssen’s Invokana.

This product will be manufactured at Lupin’s Pithampur facility in India.

Canagliflozin is a sodium-glucose co-transporter 2 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; and 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.

[Read more: Lupin receives tentative FDA nod for 2 generics]

Canagliflozin tablets (Invokana) had a market value of approximately $561 million, per IQVIA September 2023 data.

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