Hi-Tech Pharmacal Co Inc has received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride with timolol maleate ophthalmic solution. Hi-Tech Pharmacal’s dorzolamide hydrochloride with timolol maleate ophthalmic solution is the generic version of Merck’s Cosopt, for the treatment of glaucoma. The company said that it has 180 days of marketing exclusivity for generic dorzolamide hydrochloride with timolol maleate ophthalmic solution, and will begin marketing the product upon the completion of Merck’s pediatric exclusivity period in October 2008.