{"id":10676,"date":"2016-10-29T00:09:48","date_gmt":"2012-10-29T00:09:48","guid":{"rendered":"http:\/\/www.viamedic.com\/blog\/?p=677"},"modified":"2012-10-29T00:09:48","modified_gmt":"2012-10-29T00:09:48","slug":"generic-wellbutrin-loses-approval-from-fda","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/current-health-news\/generic-wellbutrin-loses-approval-from-fda\/","title":{"rendered":"Generic Wellbutrin Loses Approval from FDA"},"content":{"rendered":"

Budeprion XL<\/a>\u00a0— a generic Wellbutrin product — is having its 300 milligram dosage product removed from the market by the FDA. —\u00a0Click to Tweet<\/a>.<\/p>\n

The product has no dangers, but it has been shown to be less effective than it\u2019s analogous brand name product, Wellbutrin XL 300 mg. The recanted FDA approval has no bearing on Budeprion XL 150 mg or generic Wellbutrin products from other companies.<\/p>\n

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Budeprion XL 300 mg has unfortunately not proven as effective as similar dosages of Wellbutrin XL. (Photo by @Doug88888 on Flickr.)<\/figcaption><\/figure>\n

How The Discovery Was Made<\/strong>
\nBudeprion and other generic Wellbutrin products first hit the market shortly after 2006, when the original US producer, GlaxoSmithKline PLC, lost its patent protection.<\/p>\n

Shortly thereafter, the market was hit by other FDA approved generic versions of Wellbutrin, which were produced by Impax\/Teva — the producer of Budeprion XL 300 mg — and other drug companies.<\/p>\n

But more recently, the FDA started receiving reports that the patients were experiencing reduced efficacy with Budeprion XL 300 mg compared to other similar drugs, specifically Wellbutrin XL 300 mg. Studies were performed, and it was shown that Budeprion XL 300 mg failed to release the active ingredient, bupropion hydrochloride, into the bloodstream at the same rate as Wellbutrin.<\/p>\n

This subtle defect doesn\u2019t affect the 150 mg dosage of Budeprion XL, and it also doesn\u2019t carry any possibility of dangerous side effects. No one has been harmed before this recall, other than through the unfortunate fact that their medicine wasn\u2019t working as effectively as it should be.<\/p>\n

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Despite being the same chemical, it appears the delivery method of Budeprion XL is slightly less effective than it should be in 300 mg dosage. (Photo by Amarand Agasi on Flickr.)<\/figcaption><\/figure>\n

Follow-Up Studies<\/strong>
\nSince the initial discovery, the FDA has begun a review of other products, covering its bases and hunting down any possible similar defects. It has asked four other companies, including Mylan Inc. and Watson Pharmaceuticals, to conduct further tests comparing their 300 mg products to their name brand analogs.<\/p>\n

Market Consequences<\/strong>
\nThe immediate market<\/a> impact of this unfortunate mistake on the part of Teva Pharmaceuticals and Impax Laboratories — the two companies responsible for Budeprion XL — wasn\u2019t disastrous, though it also wasn\u2019t flattering. Within just 24 hours of the FDA announcing its withdrawal of Budeprion XL from the market, shares of Teva had fallen 1%, Impax shares moved fractionally lower, and GlaxoSmithKline shares rose about 1%.<\/p>\n","protected":false},"excerpt":{"rendered":"

Budeprion XL\u00a0— a generic Wellbutrin product — is having its 300 milligram dosage product removed from the market by the FDA. —\u00a0Click to Tweet. The product has no dangers, but it has been shown to be less effective than it\u2019s analogous brand name product, Wellbutrin XL 300 mg. The recanted FDA approval has no bearing […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_autoblog_aioseo_focus_keyphrase":"","_autoblog_aioseo_title":"","_autoblog_aioseo_description":"","footnotes":""},"categories":[18],"tags":[],"class_list":["post-10676","post","type-post","status-publish","format-standard","hentry","category-current-health-news"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t