Small-Cap Pharma Stock Jumps 9% on USFDA Approval for Glaucoma Solution

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Small-Cap Pharma Stock Jumps 9% on USFDA Approval for Glaucoma Solution
Credit: © Reuters.

By Malvika Gurung -- Shares of the pharmaceutical company Alembic Pharmaceuticals (NS: ALEM ) jumped 8.7% to Rs 509.4 apiece on Friday after the small-cap company announced receiving approval from the US health regulator for a product used in the treatment of elevated eye pressure.

The Gujarat-based pharma company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brimonidine Tartrate Ophthalmic Solution, 0.15%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) of the Illinois-based pharma company AbbVie (NYSE: ABBV ) Inc’s ‘Alphagan P Ophthalmic Solution, 0.15%’, Alembic said on Friday, March 31, 2023.

To shed light on the approved ANDA, Brimonidine Tartrate Ophthalmic Solution is an ‘alpha-adrenergic receptor agonist’, which is indicated for reducing elevated intraocular pressure (IOP) in patients having open-angle glaucoma or ocular hypertension.

Alembic Pharmaceuticals has received 180 ANDA approvals from the health regulator (USFDA), of which 156 are final and 24 are tentative in nature.

According to IQVIA data for the year ending in December 2022, Brimonidine Tartrate Ophthalmic Solution, 0.15% has an estimated market size of $ 97 million.

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