Alembic Pharmaceuticals announced that the Company 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 US$ 35 million for twelve months ending December 2018 according to IQVIA
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