Hi-Tech launches generic Cosopt without exclusivity
This article was originally published in Scrip
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.
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