9-Oct-12 7:00 AM  CST

Market Withdrawal of Teva’s 300mg Tablet of Generic Wellbutrin XL

 
The Food and Drug Administration has asked for a voluntary market withdrawal of Teva Pharmaceuticals 300 mg tablet of generic Wellbutrin XL. As of right now, the 150 mg tablet of Budeprion XL is not included in the voluntary market withdrawal. The prescription medication is manufactured by Impax and marketed by Teva.    

The market withdrawal comes after complaints from consumers that their depression symptoms worsened, had suicidal thoughts, and also experienced headaches.   Here’s the science behind the problem with the drug.  Bioequivalence testing was never done on the drug and the drug approval was based on tests of the 150 mg tablet.  In addition, the Teva equivalent did not act as a once-a-day formula, but acted as an immediate release formula. 

According to a recent report on Web MD.com and the Generic Pharmaceutical Association (GPhA), more than 10,000 FDA approved generic drugs in the United States of 4 billion prescriptions in the U.S yearly, 80% are filled using generic drugs. 

Pharmacy technicians should be aware of this voluntary market withdrawal and inform their fellow pharmacy technicians of the drug news as questions may arise concerning the generic prescription medication and the release of this new information. 

Sources: 
Neporent, Liz.  “FDA Asks For Voluntary Recall Of Popular Antidepressant.”  ABC News.  Web.  4 Oct 2012. 

“Questions And Answerers Regarding Market Withdrawal Of Budeprion XL 300 mg Manufactured By Impax and Marketed By Teva.”  FDA.  Web.  5 Oct 2012.  

DeNoon, Daniel, J.  “High Dose Generic Wellbutrin XL Withdrawn.”  WebMD. Web.  5 Oct 2012.

For additional information on this article, please contact:
 
Jennifer O'Reilly
 
Source: NPTAnews  
http://www.pharmacytechnician.org

Tendenci™ User Home © 2004 Tendenci™ software by Schipul - "The Web Marketing Company" | www.schipul.com