Gland Pharma 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.