Alembic Pharma gets USFDA’s approval for Bimatoprost Ophthalmic Solution

23 Jan 2020 Evaluate

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bimatoprost Ophthalmic Solution, 0.03%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Latisse Ophthalmic Solution, 0.03%, of Allergan, Inc. (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 $ 57 million for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 113 ANDA approvals (101 final approvals and 12 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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