Alembic Pharma gets USFDA nod for Acetazolamide extended release capsules

Acetazolamide extended-release capsule is therapeutically equivalent to the reference listed drug, Diamox Sequels, 500 mg, of Teva Branded Pharmaceutical Products R&D Inc.

New Delhi: Drug firm Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator for Acetazolamide extended-release capsules, used for the treatment of various kinds of glaucoma.

The approved product is therapeutically equivalent to the reference listed drug, Diamox Sequels, 500 mg, of Teva Branded Pharmaceutical Products R&D Inc.

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The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Acetazolamide extended-release capsules, 500 mg," Alembic Pharmaceuticals said in a BSE filing.

Quoting IQVIA sales data, the company said, Acetazolamide extended-release capsules, 500 mg, has an estimated market size of $13.1 million for 12 months ending December 2018.

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Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.

The company said it now has 87 ANDA approvals from the USFDA.

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