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20-Feb2019

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

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.


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