Alembic Pharmaceuticals Announces FDA Approval for Glaucoma Treatment Acetazolamide

India-based Alembic Pharmaceuticals announced that it has received approval from the FDA for its abbreviated new drug application (NDA) for Acetazolamide extended-release capsules, 500 mg. The approved NDA is therapeutically equivalent to the reference listed drug product Diamox Sequels, 500 mg, of Teva Branded Pharmaceutical Products.

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