U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 13:51:02 -0500 (CDT)
Subject: Drug Information Update- Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

The U.S. Food and Drug Administration received reports of loss of antidepressant effect and new or worsening side effects in some patients who switched from the brand name drug, Wellbutrin XL, used to treat depression, to a generic version of the drug. The FDA reviewed the safety and effectiveness of a generic version, bupropion hydrochloride extended release 300 milligram tablets, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals. The agency evaluated adverse event reports and other data in order to provide the public with current drug safety information.

 

The FDA has completed its evaluation of Teva’s version of generic bupropion extended- release tablets, marketed as Budeprion XL 300 milligram. The FDA considers Teva’s generic drug to be a safe and effective choice for consumers in treating depression, as it has been shown to meet all requirements for approval, including bioequivalence to the branded drug, Wellbutrin XL 300 milligram. The FDA’s conclusions can be found in a review of therapeutic equivalence that was released today.   

 

Wellbutrin XL is owned by GlaxoSmithKline, Philadelphia, and manufactured by Biovail, Mississauga, Ontario, Canada.

 

Budeprion XL is manufactured by Impax Laboratories, Hayward, Calif., and distributed by Teva Pharmaceuticals, North Wales, Penn.

 

For more information, please visit:

 

Review of Therapeutic Equivalence: Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg

www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm

 

Consumer Education: Generic Drugs

www.fda.gov/cder/consumerinfo/generic_text.htm

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 31 Mar 2008 13:28:01 -0500 (CDT)
Subject: The April 2008 MedSun Newsletter is now available...

Medical Product Safety Network

Highlighted articles include:

 

Epidural Conduction Device Fractures and Complications of Retained Fragments

The article gives tips to nurse anesthetists on how to prevent potential problems through good practices and encourages the practice of recording catheter retention in medical records and informing patients of retained devices...

 

FDA Requests Comments on Dissemination of Information on Unapproved Uses of Medical Products

The U.S. Food and Drug Administration (FDA) issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices...

 

FDA Approves Drug-Eluting Stent for Clogged Heart Arteries

FDA has approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart...

 

Managing Medical Device Recalls

Provides tips to healthcare facilities on what to do when a medical device recall has been initiated...

 

Surveyed hospitals: Only 10-30 Percent Use Successful CA-UTI Prevention Practices

A recent national survey of urinary tract prevention infection practices revealed that more than 50 percent of hospitals did not have a monitoring system for patients with indwelling catheters and greater than 70 percent did not monitor the duration the catheter was in place...

 

Testing the Technology Acceptance Model for Evaluating Healthcare Professionals Intention to Use an Adverse Event Reporting System

The results indicated that perceived usefulness, perceived ease of use, subjective norm, and trust had a significant effect on a professional's intention to use an adverse event reporting system...

 

Prevent Life-Threatening Communication Breakdowns

A patient died after uneventful elective surgery because his implantable cardioverter defibrillator (ICD) was not turned back on after the procedure...

 

FDA Reminds Healthcare Professionals About Falsely Elevated Glucose Levels

FDA is reminding healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone based glucose monitoring systems...

 

 

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The content on the Homepage has been updated to reflect this month's Newsletter items.  This information can be viewed by clicking here. 

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420