R-Tech Ueno: Announcement of Approval of sNDA for RESCULA® Ophthalmic Solution and Start of Commercialization
12/19/2012 9:51:34 AM
TOKYO--(BUSINESS WIRE)--R-Tech Ueno (JASDAQ:4573): Sucampo Pharmaceuticals, Inc. (hereinafter referred to as "Sucampo") announced that it has received approval by the U.S. Food and Drug Administration (FDA) of the supplemental new drug application (sNDA) to change to Package Insert (PI) for RESCULA® ophthalmic solution. (Please refer to Sucampo press release as of December 12, 2012) The approved change to the PI will make it possible to prescribe RESCULA® ophthalmic solution as a first-line therapeutic agent for open-angle glaucoma or ocular hypertension, or to concomitantly administer it with other intraocular pressure (IOP) lowering agents. Open-angle glaucoma is the most common form of glaucoma. RESCULA® is a BK (Big Potassium) channel activator, and is different from other IOP lowering agents. Following this approval, Sucampo intends to commercialize RESCULA® ophthalmic solution on the US market in the first quarter of 2013.