Alembic Pharma gets USFDA’s nod for Acetazolamide Extended-Release Capsules

20 Feb 2019 Evaluate

Alembic Pharmaceuticals (Alembic) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Acetazolamide Extended-Release Capsules, 500 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Diamox Sequels, 500 mg, of Teva Branded Pharmaceutical Products R&D Inc. Acetazolamide Extended-Release Capsules, 500 mg is indicated for adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.

Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent. Acetazolamide Extended-Release Capsules, 500 mg has an estimated market size of $13.1 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 87 ANDA approvals (74 final approvals and 13 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

899.90 -2.30 (-0.25%)
05-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1804.95
Dr. Reddys Lab 1275.05
Cipla 1520.55
Zydus Lifesciences 931.45
Lupin 2097.65
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×