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REMERON(R) Now Approved in Japan for the Treatment of Depression in Adult Patients
Date:7/9/2009

eveloped severe neutropenia. All patients recovered after discontinuation of therapy. If a patient develops sore throat, fever, stomatitis or other signs of infection, along with low WBC, treatment with REMERONSolTab(R) should be discontinued and the patient should be closely monitored.

It is recommended that REMERONSolTab(R) not be used in combination with a monamine oxidase inhibitor (MAOI), or within 14 days of initiating or discontinuing therapy with an MAOI.

In US controlled clinical trials of 6-week duration, the most commonly reported adverse events associated with REMERON(R) (mirtazapine) Tablets therapy were: somnolence (54%), increased appetite (17%), weight gain (12%), and dizziness (7%). In short-term clinical trials, 10.4% of patients discontinued therapy due to somnolence. In a pool of premarketing US studies, including patients in long-term, open-label treatment, 8% of patients discontinued therapy due to weight gain.(2)

Full Prescribing Information is available at https://www.spfiles.com/piremeronsoltab.pdf

About Schering-Plough Corporation

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.

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