Generic antidepressant taken off the market
After reviewing new data, FDA has concluded that Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc., is not therapeutically equivalent to GlaxoSmithKline’s Wellbutrin XL 300 mg.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
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Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
