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Aurobindo Receives FDA Approval for Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, 2%/0.5% (10mL bottles)

Published: May 17, 2021

East Windsor, N.J. –Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, 2% / 0.5% (10 mL bottles). Aurobindo Pharma’s Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, are an AT-rated generic equivalent to the reference listed drug (RLD), Cosopt® Ophthalmic Solution, 2% / 0.5% marketed by Akorn Operating Company LLC.

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution is indicated for:

  • Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers