IRIS International, Inc., of Chatsworth, Calif., after extensive consultation with the FDA, plans to resubmit its 510(k) application for the company's NADiA PSA ultrasensitive diagnostic test with a prognostic claim for identifying post-prostatectomy patients at low risk of prostate cancer recurrence.

At the FDA's request, U.S. marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc., of Miami.

The FDA has approved two single-pill combination drugs, Diovan HCT (valsartan and hydrochlorothiazide) and Exforge (amlodipine and valsartan), as first-line treatments in patients likely to need multiple drugs to manage hypertension.

The Medicines Company of Parsippany, N.J., has received approval for its IV-administered Cleviprex (clevidipine butyrate) injectable emulsion for reducing BP when oral treatment is neither feasible nor desirable.

Animas Corporation of West Chester, Pa., has received clearance for its OneTouch Ping Glucose Management System, with the first full-feature insulin pump that wirelessly communicates with a blood glucose meter-remote.

The FDA announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin), a topical cream indicated for treatment of non-healing leg and foot ulcers in diabetic patients.

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.