Resources for Food and Drug Administration (FDA)

FDA Deems Generic Wellbutrin XL to Be Safe

online.wsj.com

The Food and Drug Administration has completed its review of a generic form of antidepressant Wellbutrin XL, and it determined the medication is safe.

The generic, made by Impax Laboratories Inc. and distributed by Teva Pharmaceutical Industries Ltd., is considered a "safe and effective choice for consumers" and meets "all the requirements for approval," the FDA said.

The FDA's review came to light in October, following an independent study published by ConsumerLab.com, which showed the generic, marketed as Budeprion XL, dissolved much more rapidly than the branded drug. The study was prompted by hundreds of postings on the People's Pharmacy Web site, in which people complained of side effects after switching to generic Budeprion XL from Wellbutrin XL.

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