Lupin Receives Approval From USFDA For Bromfenac Ophthalmic Solution

Lupin Receives Approval From USFDA For Bromfenac Ophthalmic Solution

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

FPJ Web DeskUpdated: Thursday, November 23, 2023, 05:02 PM IST
article-image
Lupin Receives Approval From U.S. FDA For Bromfenac Ophthalmic Solution | Image: Wikipedia (Representative)

Global pharma major Lupin Limited (Lupin) on Thursday announced that it 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 firstto-file for this product and is eligible for 180-day exclusivity, the company announced through an exchange filing.

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.

Bromfenac Ophthalmic Solution (RLD Prolensa®) had estimated annual sales of USD 185 million in the U.S. (IQVIA MAT September 2023).

Lupin Limited shares

The shares of Lupin on Thursday at 3:30 pm IST closed at Rs 1,197.35, down by 1.74 percent.

RECENT STORIES

OYO Withdraws DRHP, To Refile IPO Post Refinancing

OYO Withdraws DRHP, To Refile IPO Post Refinancing

AI-Driven Sustainable Development Needs Tech Deployment Across Economic and Social Sectors: DoT

AI-Driven Sustainable Development Needs Tech Deployment Across Economic and Social Sectors: DoT

Gujarat GST Commissioner Grabs 620 Acres From Entire Village Near Maharashtra's Mahabaleshwar

Gujarat GST Commissioner Grabs 620 Acres From Entire Village Near Maharashtra's Mahabaleshwar

Market Rush On Weekend: Stock Exchanges To Conduct Special Trading Session On Saturday 18, May

Market Rush On Weekend: Stock Exchanges To Conduct Special Trading Session On Saturday 18, May

Extreme Poverty In Rural Areas Largely Conquered: Dr Arvind Panagariya At CII Summit

Extreme Poverty In Rural Areas Largely Conquered: Dr Arvind Panagariya At CII Summit