Alembic Pharma gets tentative USFDA approval for ophthalmic solution

New Delhi: 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 percent 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.