Gland Pharma receives USFDA tentative approval for Brimonidine Tartrate Ophthalmic Solution
Gland Pharma received tentative USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC). The product is bioequivalent to Bausch & Lomb's Lumify. The US market for this product was approximately USD 39 million (₹323 crore) for the twelve months ending September 2025.
The tentative approval for an ophthalmic solution with a reported US sales of USD 39 million (₹323 crore) indicates a moderate potential revenue stream and market impact for Gland Pharma.
The company has received a tentative approval from the USFDA for a new ophthalmic solution, which is a positive development for its product portfolio and market presence in the US.
Gland Pharma Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC).
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lumify Ophthalmic Solution, 0.025%, marketed by Bausch & Lomb Inc. The ophthalmic solution is indicated for relieving redness of the eye.
According to IQVIA data, the product generated approximately USD 39 million (₹323 crore) in US sales for the twelve months ending September 2025. Gland Pharma, established in 1978, is a generic injectable and ophthalmic-focused pharmaceutical company with a global presence in over 60 countries.
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