William Weber

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Approval for Continuous Glucose Monitor

Abbott Pharmaceuticals’ FreeStyle Navigator Continuous Glucose Monitoring System, which provides minute-by-minute information about the rate and direction of changes in blood sugar levels, has been approved for diabetics.

Clearance for Noninvasive Bladder Monitor Approved

Urodynamix Technologies Ltd., of Vancouver, Canada, announced that its worldwide distribution partner, Laborie Medical Technologies Inc., received approval to market their urodynamic equipment with the Tetra Bladder Monitor System for noninvasive bladder testing in the United States.

Agency to Review Study Data on Cholesterol-Lowering Drug

The FDA issued an Early Communication regarding its ongoing review of Vytorin (ezetimibe and simvastatin) based on preliminary results from the recently completed ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) study on this cholesterol-lowering drug.

Welchol

Approval for Adjunctive Drug to Treat Type 2 Diabetes

The FDA has approved Welchol (colesevelam hydrochloride) to reduce blood glucose in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other agents, according to Daiichi Sankyo, Inc., of Parsippany, N.J.

Manufacturing Issue Delays Restart of CIS Drug

Indevus Pharmaceuticals, Inc., of Lexington, Mass., has received a non-approvable letter from the FDA for Valstar (valrubicin solution), the only approved product for therapy of bacillus Calmette-Guérin-refractory carcinoma in situ of the urinary bladder.

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