Budeprion XL — a generic Wellbutrin product — is having its 300 milligram dosage product removed from the market by the FDA. — Click to Tweet.
The product has no dangers, but it has been shown to be less effective than it’s 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.
How The Discovery Was Made
Budeprion and other generic Wellbutrin products first hit the market shortly after 2006, when the original US producer, GlaxoSmithKline PLC, lost its patent protection.
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.
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.
This subtle defect doesn’t affect the 150 mg dosage of Budeprion XL, and it also doesn’t 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’t working as effectively as it should be.
Follow-Up Studies
Since 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.
Market Consequences
The immediate market impact of this unfortunate mistake on the part of Teva Pharmaceuticals and Impax Laboratories — the two companies responsible for Budeprion XL — wasn’t disastrous, though it also wasn’t 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%.
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