Monday, January 21, 2013

Are generics bioequivalent?

From the Wall Street Journal on 3 October 2012:

In a statement posted on its website Wednesday, the FDA said it started receiving reports from patients who were experiencing reduced efficacy after being switched from Wellbutrin XL 300 mg to its generic counterparts. The agency said the problems appear to be associated with the Impax/Teva product.


The U.S. Food and Drug Administration said Wednesday the product, Budeprion XL 300 milligrams, which is manufactured by Impax Laboratories Inc. and marketed by Teva Pharmaceuticals USA Inc., "is not therapeutically equivalent to Wellbutrin XL 300 mg" or the extended-release version of Wellbutrin.

In a post titled A Drug Recall That Should Frighten Us All About The FDA

The People’s Pharmacy, a well-known syndicated radio and newspaper columnist husband and wife team, notified the FDA that hundreds of patients had logged their own complaints of side effects with the then-recently approved generic version of Wellbutrin XL. The FDA brushed off the People’s Pharmacy and others that raised the issue, stating that they had faith that the drugs were equivalent and that perhaps the patients, who had mental disease, were more prone to perceived problems with a change in the medication than others. This was seen by many as essentially telling patients “it’s all in their head.” After several more years and public outcry, the FDA was forced to take action.


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