Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bimatoprost Ophthalmic Solution, 0.01%.
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), LUMIGAN ophthalmic solution 0.01%, of Allergan Inc. Bimatoprost Ophthalmic Solution, 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. According to IQVIA, Bimatoprost Ophthalmic Solution, 0.01% has an estimated market size of $704 million for twelve months ending December 2018.
Alembic now has a total of 100 ANDA approvals (88 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.