Hi-Tech Pharmacal got tentative approval for Dorzolamide Hydrochloride with Timolol Maleate Ophthalmic Solution

Hi-Tech announced that the USFDA has granted tentative approval to the Company's Abbreviated New Drug Application for Dorzolamide hydrochloride with Timolol maleate ophthalmic solution. Hi-Tech's dorzolamide hydrochloride with timolol maleate ophthalmic solution is the generic equivalent of Cosopt. Cosopt is indicated for lowering pressure in the eye to normal levels, and a treatment for glaucoma. It got USFDA approval in April 1998, and is supplied by Merck. According to IMS, Merck's Cosopt had sales of $334 million in 2007. The Company believes that it has 180 days of marketing exclusivity for generic version, and will begin marketing the product upon the completion of Merck's pediatric exclusivity period in October 2008.