Alembic Pharmaceuticals receives USFDA approval for Timolol Maleate Ophthalmic Gel Forming Solution

Timolol Maleate Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Oct 26, 2020 10:10 IST India Infoline News Service

Alembic Pharmaceuticals
Alembic Pharmaceuticals Limited today announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Timoptic-XE Ophthalmic Gel Forming Solution, 0.25% and 0.5%, of Bausch Health US, LLC, said the company. Timolol Maleate Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Alembic has been granted a Competitive Generic Therapies (CGT) designation for this ANDA and it is eligible for 180 days of . CGT exclusivity as it is the first approved ANDA. Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% has an estimated market size of US$ 71 million for twelve months ending June 2020 according to IQVIA. This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Pvt Ltd.

Alembic has a cumulative total of 134 ANDA approvals (117 final approvals and 17 tentative approvals) from USFDA.
Alembic Pharmaceuticals Ltd was trading at Rs959.40 down by Rs14.3 or 1.47% from its previous closing of Rs973.70 on the BSE, at 10:05 am.

The scrip opened at Rs980 and has touched an intraday high and low of Rs984.05 and Rs959.40 respectively.

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