FDA announced certain generic Wellbutrin to be pulled off of the shelves.
The 300 mg generic version of Wellbutrin XL made by Impax Laboratories and marketed by Teva Pharmaceuticals is being recalled. Unusually, the recall is not because the medication has side effects, but rather because the medication doesn’t work at all.
This problem was not a batch issue; here there was a problem with every pill manufactured during the five years that the company had been selling the drug.
Generic Wellbutrin Drug Approval
The problem is that the FDA approves drugs without testing them if they are generic Wellbutrin versions of approved drugs. The FDA operates with the understanding that if any dosage strength a drug company submits works, they approve all higher dosages.
At the end of 2006, the FDA began approving generic Wellbutrin versions of Wellbutrin XL, a popular anti-depressant. The drug comes in two dosages, 150mg and 300mg — the 150mg dose is often used for smoking cessation while the 300mg dose is the normal anti-depressant level dose. The FDA approved generics from Impax, Anchen, Actavis, Watson, and Mylan — and immediately got complaints about reduced efficacy and increased side effects.
In response, the FDA asked Impax to do their own study, which was never completed, so the FDA was forced to do their own starting in 2010. In 2012 they finally completed it.
Pulling the Generic Drug
In August 2012, over 5 years after the first complaints, the FDA determined that the 300mg dose from Impax is ineffective and does not deliver the correct dosage. Despite the August determination, they did not pull the drug until October. From their press release:
FDA has approved five generic Wellbutrin versions of Wellbutrin XL 300 mg. Each of these generics was approved based on bioequivalence studies comparing the 150 mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed directly on the 300 mg strength of the products. Rather, the bioequivalence studies were performed using the 150 mg strength, and the results were extrapolated to establish bioequivalence of the 300 mg product.
FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300 mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the Agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products.
Changes to Generic Drug Approval Process
The FDA has told other generic drug companies they must perform their own tests and submit the results by March 2013, attempting to get more accurate information but also not taking the independent, regulatory role and letting the companies do it themselves.
If you or a loved one has taken the generic Wellbutrin version of Wellbutrin XL and have since suffered dangerous side effects such as the medication not working, you may be entitled to compensation. The lawyers at the Strom Law Firm are now accepting cases nationwide. We offer free consultations to discuss the facts of your case, so contact us today (803) 252-4800.