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FDA approves Indian firm Alembic's generic of Teva's Diamox

Published on 20/02/19 at 10:48am

The US FDA has approved Guajarati firm Alembic Pharmaceuticals generic version of Teva’s Acetazolamide sold under the brand name Diamox, a medication used for the treatment of various conditions including glaucoma, epilepsy, altitude sickness, periodic paralysis, idiopathic intracranial hypertension, and heart failure.

The FDA granted the drug approval under the Abbreviated New Drug Application (ANDA) application scheme for new generic drugs.

The US regulator granted approval to Alembic’s Acetazolamide Extended-Release Capsules, 500 mg which are therapeutically equivalent to Teva’s listed drug product Diamox Sequels, 500 mg.

The drug is indicated for adjunctive treatment of chronic simple glaucoma, secondary glaucoma, and pre-operatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure.

The capsules had an estimated market worth $13.1 million for the 12 months ending in December 2018.

As of now, Alembic have a total of 87 separate ANDA approvals, 74 of which are final approvals and 13 of which are tentative from the FDA.  

Louis Goss

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