Gland Pharma gets USFDA’s tentative nod for Brimonidine Tartrate Ophthalmic Solution
The product is indicated to relieve redness of the eye
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.
