Sucampo announces commercial availability of Rescula in U.S. pharmacies Sucampo Pharmaceuticals announced that Rescula 0.15% is now available by prescription across the United States. The FDA approved a sNDA for Rescula for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension on December 7, 2012.
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Sucampo announces publication of NICE recommendatoin for Amitiza Sucampo announced that the United Kingdom's National Institute of Health and Care Excellence has published the technology appraisal guidance recommending the use of AMITIZA in the treatment of chronic idiopathic constipation and associated symptoms in adults who have failed laxatives. The NICE guidance recommends AMITIZA as an option for treating CIC for adults in whom treatment with at least 2 laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and for whom invasive treatment for constipation is being considered.
Sucampo says FDA approves addition of Nitto Medic as Rescula production site Sucampo Pharmaceuticals disclosed in a regulatory filing that on July 15 the company received an approval letter from the FDA to its prior approval supplement in response to FDA’s review of the revised Drug Master File of R-Tech Ueno. The approval provides for the addition of Nitto Medic of Toyama, Japan as a new production site for Rescula 0.15%. "The company has adequate supply of RESCULA to be able to supply the U.S. market into the first quarter of 2015," Sucampo added.