Alembic Pharma gets tentative USFDA nod for ophthalmic solution

Drug firm Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for Bimatoprost Ophthalmic Solution, used to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Alembic said it is currently in litigation with Allergan in District Court of New Jersey and the launch of this product will depend on the outcome of litigation.

The tentatively approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product (RLQ), LATISSE ophthalmic solution, 0.03 per cent of Allergan," Alembic Pharmaceuticals said in a BSE filing.

Quoting IQVIA sales data, the company said, Bimatoprost Ophthalmic Solution had an estimated market size of USD 63 million for 12 months ending December 2017.


The company said it now has a total of 76 ANDA approvals from the USFDA.

Shares of Alembic Pharmaceuticals were trading at Rs 609 apiece, up 2.79 per cent, on the BSE.