Gland Pharma Receives Tentative USFDA Approval for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC)

Gland Pharma Limited, a generic injectable & ophthalmic-focused pharmaceutical company, has received 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. This product is indicated to relieve redness of the eye. According to IQVIA, the product had US sales of approximately USD 39 million for the twelve months ending September 2025.