Alembic Pharmaceuticals announces USFDA Final Approval for Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%

Alembic Pharmaceuticals Limited (Alembic) 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. 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.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.973.7 as compared to the previous close of Rs. 1011.6. The total number of shares traded during the day was 30299 in over 3065 trades.

The stock hit an intraday high of Rs. 1032.15 and intraday low of 966.45. The net turnover during the day was Rs. 30196948.

Source : Equity Bulls

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