• FDA Signs Off on Par Pharma's Bioequivalence Study on Generic Wellbutrin Even as Questions Remain

    The US Food and Drug Administration (FDA) has approved a supplemental Abbreviated New Drug Application (sNDA) sponsored by Par Pharmaceuticals for a 300 mg, extended-release version of the popular antidepressant Wellbutrin XL (bupropion). The approval appears to be the first since the agency formally withdrew a nearly identical drug from the market several months ago after the product was found to not be bioequivalent to the reference listed drug (RLD). Background In Se...
  • A Generic Conundrum: How do you Study a Drug that has Been Withdrawn from the Market?

    In March 2013, the US Food and Drug Administration (FDA) formally withdrew approval for Impax Laboratory's buproprion hydrochloride extended release 300 mg (Budeprion XL 300 mg), saying the drug had been found to not be bioequivalent to its reference listed drug, Wellbutrin XL 300 mg. Soon thereafter, the agency announced it was looking for a company to further study the issue of why Impax's drug wasn't bioequivalent when several other generic products did not exhibit sim...
  • Teva Withdraws Antidepressant After Bioequivalence Concerns Validated by FDA

    The US Food and Drug Administration (FDA) has asked Israeli generic drug manufacturer Teva Pharmaceuticals to stop distribution of Budeprion XL 300, a generic version of the antidepressant Wellbutrin XL 300, after becoming aware of significant differences between the two drugs. The request-agreed to by Teva-comes five years after a similar review conducted by FDA came to the opposite conclusion. In 2007, FDA conducted a review of the therapeutic equivalence between...