Other safety alerts
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| The United States: FDA Update: Budeprion XL 300mg Not Therapeutically Equivalent to Wellbutrin XL 300mg |
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The US Food and Drug Administration (FDA) has reviewed new data that indicate Budeprion XL 300mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc., is not therapeutically equivalent to Wellbutrin XL 300mg. Impax has requested that the Agency withdraw approval of Budeprion XL 300mg extended-release tablets. Impax and Teva have stopped shipping the product and are issuing detailed information to their customers. This announcement relates only to Budeprion XL 300mg manufactured by Impax and marketed by Teva. It does not affect the Impax/Teva Budeprion 150mg product or generic bupropion products made by other manufacturers. FDA advised that patients taking Budeprion XL 300mg as a substitute for Wellbutrin XL 300mg should talk with their healthcare professionals if they have questions about taking this medication.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/../ucm322161.htm
In Hong Kong, Budeprion XL 300mg is not a registered pharmaceutical product.
Ends/ Thursday, October 04, 2012
Issued at HKT 12:00 |
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