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  • FDA Formally Withdraws Approval for Second Generic Version of Popular Antidepressant

    This week the US Food and Drug Administration (FDA) formally-and quietly-withdrew a generic version of GlaxoSmithKline's Wellbutrin XL (bupropion) 300 mg following a determination that the drug was not bioequivalent to its originator. Background The withdrawal of the generic buproprion, an antidepressant marketed by Watson Pharmaceuticals, follows similar concerns raised about other generic versions of bupropion. In September 2012, FDA announced that it had asked Israe...
  • Second Generic Version of Popular Antidepressant to be Pulled from Market for Bioequivalency Issues

    The US Food and Drug Administration (FDA) on Friday quietly announced that a second generic version of Wellbutrin XL 300 mg, a popular antidepressant manufactured by GlaxoSmithKline, has been found to not be bioequivalent to the drug and will be pulled off the market. Background In September 2012, FDA announced that it had asked Israel-based manufacturer Teva Pharmaceuticals to  stop distributing Budeprion XL (bupropion) 300 mg  after it conducted testing and ...
  • 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  • A Generic Conundrum: How do you Study a Drug that has Been Withdrawn from the Market?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...
  • In Response to Bioequivalence Concerns, FDA Reissues Standards for Popular Antidepressant

    Late in 2012, the US Food and Drug Administration (FDA) faced a rare and potentially problematic dilemma: Despite its repeated assurances that generic products were therapeutically equivalent to their reference product, it was forced to admit that several generic versions of the antidepressant Wellbutrin XL 300 mg (bupropion) were, in fact, different. Now, in response to criticism and its own promises to take another look at some of its therapeutic standards, the agency i...
  • Facing Criticism, FDA Rethinking Some Therapeutic Equivalence Standards

    US regulators are taking a second look at the way generic drug applications for extended-release generic drug obtain approval several weeks after finding that Teva Pharmaceuticals and Impax Laboratories' Budeprion XL 300mg, supposedly generic to GlaxoSmithKlines' Wellbutrin 300mg, was in fact not therapeutically equivalent. The finding was a setback for the US Food and Drug Administration (FDA), which has fastidiously maintained that nearly all drugs approved through i...
  • 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...