Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trusopt Ophthalmic Solution, 2%, of Merck Sharp & Dohme Corp. Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% has an estimated market size of $35 million for twelve months ending December 2018 according to IQVIA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
