Generic Cosopt approved

April 18, 2008

Hi-Tech Pharmacal Co., Inc. has announced that the FDA has granted tentative approval to the company's Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride with timolol maleate ophthalmic solution, the generic equivalent of Merck's Cosopt.

Hi-Tech Pharmacal Co., Inc. has announced that the FDA has granted tentative approval to the company's Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride with timolol maleate ophthalmic solution, the generic equivalent of Merck's Cosopt.

Hi-Tech will begin marketing the product upon the completion of Merck's paediatric exclusivity period in October 2008. According to IMS, Merck's Cosopt had sales of $334 million in 2007.