Oral Drug for Chronic Hepatitis Cleared
Tyzeka (telbivudine) from Novartis Pharmaceuticals has been approved as a once-a-day oral treatment for adults with chronic hepatitis B virus (HBV).
Diagnosis & Disease Information
First in New Class of Diabetes Drugs Cleared
Merck & Co. has received approval of its New Drug Application (See FDA News, April 2006) for Januvia (sitagliptin phosphate) tablets, the first in a new class of drugs known as DPP-4 inhibitors.
Careful Patient Monitoring Advised for Bleeding Inhibitor
The FDA has issued interim recommendations for using Trasylol (aprotinin injection) until a study determines if the drug increases the likelihood of death, serious kidney damage, congestive heart failure, and strokes.
New Labeling to Indicate Lowering of “Bad” Cholesterol
Merck and Schering-Plough Pharmaceuticals have received approval to include new data in their label for Vytorin (ezetimibe/simvastatin), which the two companies co-market.
Approvable Letter Issued for Incontinence Implants
Uroplasty, Inc., of Minnetonka, Minn., announced that it has received an approvable letter from the FDA following the agency’s scientific review of the safety and efficacy of Macroplastique Implants for female stress urinary incontinence.
Data Submitted for Advanced Renal Cancer Drug
Wyeth Pharmaceuticals has submitted a New Drug Application (NDA) for Torisel (temsirolimus) for treating advanced renal cell carcinoma.
Sensor-Based BP Monitor Cleared
Medwave Inc., of Danvers, Mass., has received clearance to market Fusion, the first completely sensor-based monitor to evaluate BP and vital signs.
Patient-Friendly Software for Diabetic Monitoring Cleared
DexCom, Inc., of San Diego has received approval for its DM Consumer Data Manager, a software program that allows diabetic patients to download and view up to 30 days of historical glucose data from their DexCom STS Continuous Glucose Monitoring Systems.
Further Data on Diabetic Retinopathy Drug Requested
Eli Lilly and Company has received an approvable letter from the FDA requesting additional supporting data for its new drug application for ruboxistaurin mesylate (proposed trade name: Arxxant), Lilly’s investigational oral therapy for diabetic retinopathy.
BPH Treatment Device Returns to Market
Celsion Corporation of Columbia, Md., has announced it will resume shipments of its Prolieve Thermodilatation system for benign prostatic hyperplasia after clearance from the FDA’s Center for Devices and Radiological Health.
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