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FDA Withdraws Approval Of Generic Antidepressant

10/08/12

  10:15:06 am, by MedBen5   , 153 words,  
Categories: News, Prescription

FDA Withdraws Approval Of Generic Antidepressant

According to WebMD, the Food and Drug Administration has announced that a generic version of the extended-relief antidepressant Wellbutrin XL doesn’t work correctly, and as such, has withdrawn its approval.

Budeprion XL 150-mg tablets were approved by the FDA in 2009 as an effective generic equivalent to the brand-name Wellbutrin XL. But comprehensive agency testing of a higher-dose (300-mg tablet) version of the drug – which didn’t begin until 2010 and was completed just weeks ago – determined that it dumped too much active ingredient too soon and failed to maintain effective drug levels.

Drug manaufacturer Teva Pharmaceutical has recalled the 300-mg version of Budeprion XL, while the lower-dose version remains on the market.

Four other companies make generic, extended-release versions of Wellbutrin XL 300 mg: Anchen, Watson, Actavis, and Mylan. The FDA has asked these manufacturers to test the drugs at full dose to ensure that they are truly equivalent to the brand name version.

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