Alembic Pharma gets USFDA nod for ophthalmic solution

Alembic Pharmaceuticals on Monday (26 October 2020) said it has received final approval from the US drug regulator for Timolol Maleate Ophthalmic Gel Forming Solution.

In a BSE filing made before market hours today, the company said that it had 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%.

It added that the ANDA had been co-developed in partnership with Orbicular Pharmaceutical Technologies. 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, Alembic Pharma said.

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, the company further said.

Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% has an estimated market size of $71 million for twelve months ending June 2020 according to IQVIA.

Alembic has a cumulative total of 134 ANDA approvals (117 final approvals and 17 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

The drug maker reported a 35.4% jump in consolidated net profit to Rs 333.37 crore on 17.4% rise in net sales to Rs 1,457.10 crore in Q2 September 2020 over Q2 September 2019.

The scrip fell 1.20% to Rs 962 on the BSE. It traded in the range of 961.25 and 984.05 so far during the day.

On a year-to-date (YTD) basis, the stock has jumped 68.56% while the benchmark S&P BSE Sensex fell 1.57% during the same period.

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