Pharmaceutical firm Lupin Ltd said on Thursday (November 23) that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning Bromfenac Ophthalmic Solution, 0.07%.
"...regarding receipt of US FDA approval for the company's 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 said in a regulatory filing.
This approval positions Lupin as the exclusive first-to-file entity for this generic equivalent of Bausch & Lomb Inc's Prolensa Ophthalmic Solution, 0.07%, making the company eligible for a coveted 180-day exclusivity period.
The Bromfenac Ophthalmic Solution, 0.07%, is specifically designed for the treatment of postoperative inflammation and the reduction of ocular pain in individuals who have undergone cataract surgery, addressing a crucial medical need.
The manufacturing of this pharmaceutical product will take place at Lupin's state-of-the-art facility in Pithampur, India.
Bromfenac Ophthalmic Solution, with its reference listed drug (RLD) being Prolensa, enjoyed estimated annual sales of $185 million in the US as of September 2023, according to IQVIA data.
The drug manufacturer reported better-than-expected earnings results for the September quarter, with its US sales surpassing the $200 million mark for the first time in almost two years, as the sales figure exceeded the analyst expectations of $185 million, standing at $213 million in Q2FY24.
Lupin reported a healthy 22% growth in revenue for the September quarter at ₹5,038 crore compared to ₹4,814.4 crore forecasted by the CNBC-TV18 poll.
Shares of Lupin Ltd ended at ₹1,196.30, down by ₹22.55, or 1.85%, on the BSE.
(Edited by : Ajay Vaishnav)
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