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Alembic Pharma receives USFDA nod for Bimatoprost Ophthalmic Solution


Alembic Pharma receives USFDA nod for Bimatoprost Ophthalmic Solution

Bimatoprost Ophthalmic Solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

New Delhi: Drug major, Alembic Pharmaceuticals Limited recently announced that the company 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.

In open-angle glaucoma, the angle in your eye where the iris meets the cornea is as wide and open as it should be, but the eye’s drainage canals become clogged over time, causing an increase in internal eye pressure and subsequent damage to the optic nerve.  

Also Read: Alembic Pharma gets USFDA nod to Tadalafil tablets for treating erectile dysfunction

Bimatoprost Ophthalmic Solution, 0.03% has 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.

Alembic Pharmaceuticals Limited, vertically integrated research and development the pharmaceutical company has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

Also Read: Alembic Pharma gets USFDA nod for Azelastine Hydrochloride Ophthalmic Solution

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