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Upon the original patent expiration, Hi-Tech Pharma was the first of many generic competitors to submit an abbreviated new drug application (ANDA) for dorzolamide hydrochloride/timolol maleate eye drops. [19] Hi-Tech Pharma's ANDA was approved on 28 October 2008. At the time, controversy surrounded the approval of this first ANDA.
The FDA recently cautioned against using dozens of kinds of eyedrops — its third warning this year — leading to some wondering whether any drops are safe to use. Eye doctors weigh in.
In August, the FDA said it had discovered fungal and bacterial contamination of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops-Eye Repair. The products contained ...
Glanatec, the trade name of the approved formulation, takes the form of an eye drop solution of 0.4% ripasudil, equivalent to 4 g of ripasudil per 1000 mL of solution. The solution is developed, marketed, and distributed by Kowa Pharmaceuticals, but the compound itself was discovered by D. Western Therapeutics Institute, [ 2 ] a company who ...
(Reuters) -The U.S. Food and Drug Administration had approved Eyenovia's eye drops to reduce inflammation and pain in patients who have undergone eye surgery, Taiwan-based Formosa Pharmaceuticals ...
Netarsudil, sold under the brand name Rhopressa among others, is a medication for the treatment of glaucoma. [1] [2] [3] In the United States, in December 2017, the Food and Drug Administration (FDA) approved a 0.02% ophthalmic solution for the lowering of elevated intraocular pressure in people with open-angle glaucoma or ocular hypertension.
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