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Hi-Tech Pharmacal receives tentative FDA approval for generic combination glaucoma drop

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AMITYVILLE, N.Y. — Hi-Tech Pharmacal's abbreviated new drug application for dorzolamide hydrochloride-timolol maleate ophthalmic solution has received tentative approval from the U.S. Food and Drug Administration, the company announced in a press release.

Hi-Tech's dorzolamide hydrochloride with timolol maleate ophthalmic solution is the generic equivalent of Merck's Cosopt and is indicated for treating glaucoma.

Hi-Tech expects to have 180 days of exclusive marketing rights for the generic drug combination and plans to begin product marketing pending the completion of Merck's pediatric exclusivity period in October 2008, the release said.