Alembic Pharmaceuticals receives USFDA ANDA approval for Dorzolamide Hydrochloride Ophthalmic Solution

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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