On August 13th, Drug firm Alembic Pharmaceuticals stated that the US health regulator has approved for Dorzolamide Hydrochloride Ophthalmic Solution. This drug is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
The product which has been approved is therapeutically equivalent to the reference listed drug Trusopt Ophthalmic
Solution, of Merck Sharp & Dohme Corp.
Alembic Pharmaceuticals reported in a BSE filing that the company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Dorzolamide Hydrochloride Ophthalmic Solution USP, 2 percent.
“Dorzolamide Hydrochloride Ophthalmic Solution USP, 2 percent, has an estimated market size of USD 35 million for twelve months ending December 2018” quoting from IQVIA data Alembic Pharmaceuticals reported.
It further adds that currently, the company has a total of 101 ANDA approvals (89 final approvals and 12 tentative approvals) from the USFDA.