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Alembic Pharmaceuticals receives USFDA final approval for Bimatoprost Ophthalmic Solution

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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 US$ 57 million for twelve months ending September 2019 according to IQVIA.

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First Published: Jan 23 2020 | 1:18 PM IST

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