USFDA approves Lupin Bromfenac Ophthalmic Solution
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.;
Mumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) 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.
The product will be manufactured at Lupin’s Pithampur facility in India.
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.
According to WHO, Cataract is a clouding of the lens in the eye that normally affects vision. Cataract, the most common cause of blindness and visual impairment, is often related to ageing. Occasionally children are born with the condition, or a cataract may develop following an eye injury, or as a result of inflammation or other diseases, such glaucoma and diabetes.
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