Alembic Pharma gets USFDA’s tentative approval for Bimatoprost Ophthalmic Solution

09 Aug 2019 Evaluate

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bimatoprost Ophthalmic Solution, 0.01%.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), LUMIGAN ophthalmic solution 0.01%, of Allergan Inc. Bimatoprost Ophthalmic Solution, 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. According to IQVIA, Bimatoprost Ophthalmic Solution, 0.01% has an estimated market size of $704 million for twelve months ending December 2018.

Alembic now has a total of 100 ANDA approvals (88 final approvals and 12 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

Alembic Pharma Share Price

979.40 -4.45 (-0.45%)
28-Mar-2024 16:01 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1620.50
Dr. Reddys Lab 6171.85
Cipla 1494.65
Zydus Lifesciences 1013.75
Lupin 1617.85
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt.Ltd.