Mumbai: Glenmark Pharmaceuticals Ltd. has received final approval from the United States Food & Drug Administration (U.S. FDA) for Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5%.
Glenmark’s Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5% has been determined by the FDA to be bioequivalent and therapeutically equivalent to Combigan Ophthalmic Solution, 0.2%|0.5%, of AbbVie, Inc., and will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million*.
Glenmark’s current portfolio consists of 196 products authorized for distribution in the U.S. marketplace and 51 ANDA’s pending approval with the U.S. FDA.
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Glenmark Pharmaceuticals Ltd.is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 11 manufacturing facilities spread across 4 continents, and operations in over 80 countries.
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