Alembic Pharmaceuticals gets USFDA tentative approval for Bimatoprost Ophthalmic Solution, 0.03%

Alembic Pharmaceuticals announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bimatoprost Ophthalmic Solution, 0.03%. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLQ), LATISSE ophthalmic solution, 0.03% of Allergan. Bimatoprost Ophthalmic Solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

Bimatoprost Ophthalmic Solution, 0.03% has an estimated market size of US$ 63 million for twelve months ending December 2017 according to IQVIA. Alembic 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.

Alembic now has a total of 76 ANDA approvals (64 final approvals and 12 tentative approvals) from USFDA.

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