William Weber

All articles by William Weber

Fixed-Dose Combination Tablet Approved for Type 2 Diabetes

Sciele Pharma, Inc., of Atlanta and Novo Nordisk Inc., of Denmark, have announced approval for PrandiMet (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also called Prandin) and the insulin sensitizer metformin for the treatment of type 2 diabetes.

Trial of Post-Op Drug for Dialysis Patients to Proceed

Special Protocol Assessment (SPA) approval has been given to Ark Therapeutics Group plc of London for a phase III pivotal trial of Trinam, a novel gene-based medicine to prevent blood vessel blockage in kidney dialysis patients who have undergone vascular access graft surgery.

New Indication for EBRT Transponders in Prostatectomy Patients

Calypso Medical of Seattle announced that the FDA has cleared a new indication for use of implantable Beacon electromagnetic transponders with its external-beam radiation therapy (EBRT), known as GPS for the Body, to continuously track the position of targeted tissue during treatment of prostatectomy patients.

Agency to Consider Silodosin to Treat BPH

The FDA has accepted a New Drug Application for silodosin, a novel alpha1-adrenoreceptor antagonist, from Watson Pharmaceuticals, Inc., of Corona, Calif. Watson is seeking approval of silodosin for the treatment of BPH symptoms.

Single-Pill Combo to Manage High Cholesterol Approved

Simcor (Niaspan/simvastatin), the first fixed-dose combination of two widely prescribed cholesterol therapies, has been approved for use along with diet to lower levels of elevated total cholesterol, LDL cholesterol, and triglycerides, and to raise HDL cholesterol in patients with complex lipid disease when treatment with monotherapies are not considered adequate.

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