Dr. Reddy’s blockbuster drug Difluprednate Ophthalmic Emulsion enters the U.S. market

INDIA – Dr. Reddy’s Laboratories has secured the U.S. Food and Drug Administration (USFDA) approval for its eye drops for post-surgery care, Difluprednate Ophthalmic Emulsion 0.05%.

Following the regulatory approval, the drug major has launched its new product in the US market for the treatment of inflammation, swelling and pain associated with ocular surgery.

The generic drug is recommended for use in the management of endogenous anterior uveitis, it is a form of eye inflammation that can cause pain, redness, and blurry vision.

Dr. Reddy’s Laboratories said that its eye drops for post-surgery care will be supplied in the United States in the coming weeks, and they will be available in 5 ml bottles packaged in retail cases of 24 packs.

The FDA-approved drug is a therapeutic generic version of Novartis AG’s Durezol. Moreover, the medication belongs to a class of drugs known as corticosteroids.

Dr. Reddy’s warned that prolonged use of corticosteroids may result in intraocular pressure (IOP) increase, and cataracts and may enhance existing bacterial infections.

The Indian drug major further cautioned that the use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

According to the company, the Durezol brand and generic had U.S. sales of approximately US$40 million MAT for the most recent twelve months ending in Nov 2022.

The multinational pharmaceutical company has expanded its portfolio of generic products in the U.S. with the launch of its Difluprednate Ophthalmic Emulsion at 0.05%.

In other news, Dr. Reddy’s announced its consolidated financial results for the quarter and the nine months that ended December 31, 2022.

The company reported that its Profit after Tax (PAT) rose by 77 percent to about US$152M (Rs 1,247.1 crore) in comparison to US$86M (Rs 706.5 crore) in the same quarter a year ago.

In addition, it witnessed a year-on-year growth of 10% in the India business that was driven by an increase in sales prices and new product launches, partly offset by a reduction in volumes for certain products.

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