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Aurobindo wins FDA approval for dorzolamide HCl and timolol maleate ophthalmic solution

By Brian Buntz | May 20, 2021

Aurobindo Pharma has received approval from FDA for its abbreviated new drug application for the glaucoma medication dorzolamide hydrochloride (HCl) and timolol maleate ophthalmic solution in 2% and 0.5% concentrations.

The product is a generic equivalent to the reference listed drug Cosopt ophthalmic solution, from Akorn Operating Company.

FDA indicates the drug to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension who don’t respond well to beta-blockers

IQVIA estimates the market size for dorzolamide HCl and timolol maleate ophthalmic solution to have a market size of $70 million for the twelve month period ending in March 2021.

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.