Mumbai Aug 13 : Pharma Major, Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2 pc.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trusopt Ophthalmic Solution, 2 pc, 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 pc has an estimated market size of USD 35 million for twelve months ending December 2018 according to IQVIA, the company said in a filing with BSE.
Alembic now has a total of 101 ANDA approvals (89 final approvals and 12 tentative approvals) from USFDA. (UNI)