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Gland Pharma gets USFDA’s tentative nod for Brimonidine Tartrate Ophthalmic Solution
Mar-04-2026

Gland Pharma has secured tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC).  

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lumify Ophthalmic Solution, 0.025%, of Bausch & Lomb Inc. It is indicated to relieve redness of the eye.

According to IQVIA, the product had US sales of around $39 million for the twelve months ending September 2025.

Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.

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