Latest-Breaking-FDA-Wellbutrin-Impax-News-Graver

From Forbes:

Pay attention, as I can’t say this seriously enough. Last week, the FDA took a drug off the market, and the reasons should send shivers of fear down the backs of consumers, investors, generic drug companies – and the FDA.

The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.

The FDA apparently approved this drug – and others like it – without testing it. The FDA just assumed if one dosage strength the drug companies submitted for approval works, then the other higher dosages work fine also. With this generic, American consumers became the FDA’s guinea pigs to see if the FDA’s assumption was right. It wasn’t.

Background

In December 2006, the first generic versions of the popular anti-depressant Wellbutrin XL were approved by the FDA.  The drug comes in two dosage strengths, 150 milligrams and 300mg. The 300mg dose is generally used for patients with more severe depression and anxiety and patients who don’t respond to the lower dose.  The FDA approved generic versions of both dosage strengths from a few generic drug companies: Teva Pharmaceuticals (manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals), Anchen, Actavis, Watson Pharmaceuticals andMylan MYL -4.18% Pharmaceuticals.  Almost immediately, the FDA started receiving reports from patients that claimed the 300mg dose was being associated with side effects and reduced efficacy.

 

 

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