Alembic Pharmaceuticals gets USFDA tentative approval for Bimatoprost ophthalmic solution

Alembic Pharmaceuticals has received tentative approval from the USFDA for its abbreviated new drug application (ANDA) for Bimatoprost ophthalmic solution, 0.03 percent. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLQ), LATISSE ophthalmic solution, 0.03 percent of Allergan. Bimatoprost ophthalmic solution, 0.03 percent is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness, and darkness. Bimatoprost ophthalmic solution, 0.03 percent has an estimated market size of USD 63 million for 12 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 the litigation. Alembic now has a total of 76 ANDA approvals (64 final approvals and 12 tentative approvals) from USFDA.