FDA Grants Tentative Approval for Hi-Tech's Generic Ophthalmic Solution
Posted on: Friday, 11 April 2008, 09:00 CDT
Hi-Tech Pharmacal has announced that the FDA has granted tentative approval for 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 Merck's Cosopt and is indicated for the treatment of glaucoma.
The company believes 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. The company has a partner for the product who will share in the profits.
Source: Datamonitor
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