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Alembic Pharma receives US FDA approval generic timoptic-XE ophthalmic gel forming solution

Our Bureau, Mumbai
Monday, October 26, 2020, 15:40 Hrs  [IST]

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for 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.

According to IQVIA, 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.

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 US FDA.


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