Hi-Tech Pharmacal Receives Final Approval for Dorzolamide Ophthalmic Solution
AMITYVILLE, N.Y.--(BUSINESS WIRE)--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the U.S. Food and Drug Administration (FDA) granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for dorzolamide ophthalmic solution, 2%. Hi-Tech’s dorzolamide ophthalmic solution is the generic for Merck's Trusopt® ophthalmic solution 2%, indicated for elevated intraocular pressure in patients with ocular hypertension or open-angel glaucoma. Trusopt® had sales of $45 million for the 12 months ended June 2008 according to IMS. Hi-Tech plans to launch generic dorzolamide ophthalmic solution 2% immediately.