Alembic Pharma gets USFDA nod for Bimatoprost Ophthalmic Solution
15/04/2019 11:58

Drug major Alembic Pharmaceuticals Limited on Monday said that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bimatoprost Ophthalmic Solution, 0.03 per cent. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Lumigan, 0.03 per cent of Allergan Sales, LLC (Allergan).

Bimatoprost Ophthalmic Solution 0.03 per cent have an estimated market size of USD 76 million for twelve months ending December 2018 according to IQVIA.

Alembic now has a total of 90 ANDA approvals (78 final approvals and 12 tentative approvals) from USFDA.