FDA Approval Activities for this Drug…

Rescula (unoprostone isopropyl) Ophthalmic Solution, 0.15%, Ciba Vision NDA 21-214 8/3/00 8/28/00 8/28/00 7/18/01 Rescula Indications: for the lowering of intraocular pressure in patients with open-angel glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication. UNOPROSTONE ISOPROPYL Solution/Drops; Ophthalmic 0.15% RESCULA NOVARTIS

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