Reports: Generic extended-release drugs to get more attention from FDA

Agency announces change to policy amid reports of differences between brand, generic drugs

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

The New York Times reported that the FDA would look at companies making generic extended-release drugs after it received reports that patients taking Impax Labs' generic version of Wellbutrin XL (bupropion) in the 300-mg strength was less effective than GlaxoSmithKline's original version. Impax and Teva, which also makes generic bupropion, have stopped marketing the drug in that strength.

The FDA said that although the problem appeared to only affect that one strength of the drug, it would start to pay closer attention to how companies make generic extended-release drugs, according to the Times. The newspaper also quoted Generic Pharmaceutical Association president and CEO Ralph Neas as saying he supported the science behind the FDA's decisions as well as continued development of that science.


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