Arkray USA, Inc., of Edina, Minn., has been cleared by the FDA to market its Glucocard 01 Blood Glucose Monitoring System, which requires no coding, displays results in seven seconds, and requires a tiny 0.3-microliter sample size.

GlaxoSmithKline has received a new indication for Avodart (dutasteride) in combination with the alpha blocker tamsulosin for the treatment of symptomatic enlarged prostate, a disease affecting half of all men over age 50.

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.

The FDA posted on its Web site a letter sent to Shire Development, Inc., of Wayne, Pa., regarding promotional materials for its Fosrenol (lanthanum carbonate) chewable tablets for end-stage renal disease.

The FDA has continued to issue safety alerts and investigate events surrounding the injectable blood thinner heparin (FDA News, April 2008) and its "clear link" to 81 deaths in U.S. patients who received doses of the drug.

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.

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.

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.

The FDA announced that Baxter Healthcare Corporation, of Deerfield, Ill., has temporarily stopped manufacturing multiple-dose vials of heparin due to reports of severe allergic reactions and hypotension in patients who receive high "bolus" doses of the drug.

AMAG Pharmaceuticals, Inc., of Cambridge, Mass., has announced that the FDA has accepted for standard review its New Drug Application (NDA) for ferumoxytol as an IV treatment of iron deficiency anemia in CKD patients.