The U.S. Food and Drug Administration (FDA) said it has asked Teva Pharmaceuticals to remove Budeprion XL 300 mg. after new testing revealed the generic drug releases its key ingredient into the blood faster that the original, popular drug, Wellbutrin XL 300 mg, made by GlaxoSmithKline.
Budeprion XL 300 mg., or buproprion hydrochloride extended-release tablets, are manufactured by Impax Laboratories Inc. and marketed by Teva Pharmaceuticals USA, Inc.
A spokeswoman for Teva said that the company stopped shipping the drug last Thursday.
This action contradicts the FDA’s previous update on the issue in 2008, when regulators said that the drugs are essentially the same. The agency recently conducted a review following hundreds of complaints from patients that Teva’s generic drug did not work and caused side effects, such as headaches, anxiety and insomnia.
Generic drugs approved by the FDA are required to be chemically equivalent to the original products, producing the same medical effects in patients.
The FDA said that its initial, incorrect ruling was based on tests of the 150 mg. version of Budeprion, assuming those results would apply to the 300 mg. version, as well. The agency said that the approach “is no longer appropriate.”
The agency completed its own study of the two pills in August, and found that Budeprion does not release into the blood at the appropriate rate as Wellbutrin. The FDA has posted this notice on their website.
Wellbutrin, chemically known as buproprion, is prescribed to treat depression, anxiety and symptoms of nicotine withdrawal.
The FDA approved the first generic versions of Wellbutrin XL in 2006. Doctors usually switch patients from brand drugs to the generics when they become available, since the cost savings is substantial, anywhere from 30 to 80 percent less.
Budeprion XL is taken once a day and is manufactured by U.S. based Impax Laboratories, Inc. and sold by Israel-based Teva Pharmaceutical Industries Ltd.
The other manufacturers of generic versions of Wellbutrin XL 300 mg., namely Anchen Pharmaceuticals Inc., Actavis, Watson Pharmaceuticals Inc. (WPI) and Mylan Inc. (MYL) have been asked to conduct their own studies to assess the bioequivalence of their 300 mg. extended release bupropion tablets to Wellbutrin XL 300 mg. The deadline for the companies to submit the data from those studies to the FDA is March 2013.
In a statement released last week, the FDA stated that Impax/Teva have stopped shipping Budeprion XL 300 mg. However, Impax/Teva’s Budeprion 150 mg. products or generic bupropion products made by other manufacturers are not affected.
It is estimated by the FDA that patients taking the 300 mg. dose of Budeprion account for merely 2 percent of the U.S. market for the drug.
Patients with a prescription for Budeprion XL 300 mg. should contact their doctor before taking this medication.
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