Impax yanks 300mg generic Wellbutrin after failing equivalence test
This article was originally published in Scrip
Executive Summary
Impax has withdrawn from the US market its generic form of extended-release bupropion hydrochloride, which was being marketed by its partner Teva as Budeprion XL 300, after regulators said the medicine failed to demonstrate therapeutic equivalence to the same dosage strength as GlaxoSmithKline's innovator product Wellbutrin XL 300mg, an antidepressant approved to treat major depressive disorder and to prevent seasonal affective disorder.