Renal Business Today - U.S. Food And Drug Administration (FDA)

Genzyme Sues Watson Over Generic Renvela Application

MORRISTOWN, N.J.—Watson Pharmaceuticals Inc. said July 12 that it has submitted an application to the U.S. Food and Drug Administration to approve a generic form of Genzyme’s phosphate binder Renvela. ...More

July 13, 2010

Posted in News, Government & Regulation

FDA Rejects Nephros Application for Hemodialfiltration System

RIVER EDGE, N.J.—In a June 30 letter to Nephros, the U.S. Food and Drug Administration said it “could not reach a substantial equivalence determination for the company's hemodiafiltration (HDF) system” in regards to its 510(k) application. ...More

July 8, 2010

Posted in News, Government & Regulation

FDA Clears APP Heparin Lock Flush Solution

SCHAUMBURG, Ill.—The U.S. Food and Drug Administration has cleared APP Pharmaceuticals to market its preservative-free Heparin Lock Flush Solution, USP in two dosage strengths, 10 USP Units/1 mL and 100 USP Units/1 mL, and will soon launch these single dose vial ...More

July 6, 2010

Posted in News, Clinical & Pharma, Government & Regulation

Baxter Recalls Colleague Infusion Pumps in U.S.

DEERFIELD, Ill.—Baxter Healthcare Corporation announced on May 3 that it will recall Colleague infusion pumps from the U.S. market pursuant to an order under its existing June 2006 consent decree with the U.S. Food and Drug Administration (FDA). ...More

May 5, 2010

Posted in News, Government & Regulation

Rockwell Appoints Singh to Scientific Advisory Board

WIXOM, Mich.—Rockwell Medical has added Ajay Singh, MBBS, FRCP (UK), MBA to its Scientific Advisory Board (SAB), according to an April 19 news release. ...More

April 19, 2010

Posted in News, Business, Clinical & Pharma, Government & Regulation

FDA Approves Generic Hypertension Drugs

The U.S. Food and Drug Administration says it has approved the first generic versions of two drugs used for the treatment of hypertension. ...More

April 13, 2010

Posted in News, Clinical & Pharma, Government & Regulation

Baxter Recalls PD Cycler After Reports of Serious Injury

DEERFIELD, Ill.—U.S. Food and Drug Administration has classified Baxter's recent Urgent Product Recall of the HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall because of the risk of serious injury or patient death, Baxter said in a March 3 news ...More

March 3, 2010

Posted in News, Business, Clinical & Pharma, Government & Regulation, Practice Management

FDA Mulls Pulling Avandia Off Market

U.S. Food and Drug Administration (FDA) officials are recommending that diabetes drug Avandia be pulled from the market because of its potential to cause heart attacks. An FDA advisory committee is being created to assess whether the drug, manufactured by GlaxoSmithKline, ...More

February 22, 2010

Posted in News, Business, Clinical & Pharma, Government & Regulation

FDA Approves Hypertension Drug for Youngsters

The U.S. Food and Drug Administration (FDA) approved Daiichi Sankyo, Inc.’s hypertension drug Benicar® (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age. Benicar was originally approved in 2002 for the treatment of hypertension in adults. ...More

February 15, 2010

Posted in News, Business, Clinical & Pharma, Government & Regulation

Study: Roche’s Weekly Diabetes Drug Cuts Blood Sugar

Roche announced results from the first five Phase III clinical trials show that taspoglutide has met the primary end-points of reduction in blood glucose compared to other diabetes treatment options. Taspoglutide, the first weekly human GLP-1 analog in late stage ...More

February 12, 2010

Posted in News, Business, Clinical & Pharma

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