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Alembic Pharmaceuticals receives USFDA approval for ANDA Bimatoprost Ophthalmic Solution

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Capital Market
Alembic Pharmaceuticals has received 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 (RLD), Lumigan, 0.03% of Allergan Sales, LLC (Allergan). Bimatoprost Ophthalmic Solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Bimatoprost Ophthalmic Solution, 0.03% have an estimated market size of US$ 76 million for twelve months ending December 2018 according to IQVIA.

Alembic now has a total of 90 ANDA approvals (78 final approvals and 12 tentative approvals) from USFDA.

 

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First Published: Apr 15 2019 | 10:25 AM IST

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