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Hi-Tech launches generic Cosopt without exclusivity

 
• By Nancy Faigen

As expected, Hi-Tech Pharmacalwas granted final FDAapproval on October 28th for its ANDA on a generic version of the glaucoma treatment, dorzolamide-timolol ophthalmic solution, comparable to Merck & Co's Cosopt, and it began shipping immediately. The FDA, however, said in its approval letter that the firm was not entitled to the 180-day exclusivity. Hi-Tech and [C#198601232:Apotex] were the only two firms that were holding tentative approvals.

As expected, Hi-Tech Pharmacalwas granted final FDAapproval on October 28th for its ANDA on a generic version of the glaucoma treatment, dorzolamide-timolol ophthalmic solution, comparable to Merck & Co's Cosopt, and it began shipping immediately. The FDA, however, said in its approval letter that the firm was not entitled to the 180-day exclusivity. Hi-Tech and Apotex were the only two firms that were holding tentative approvals.

Merck has also launched an authorised generic of both its Cosopt and Trusopt solutions through Prasco Laboratories. Cosopt has annual sales of around $342 million.

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