FDA Investigates Generic Wellbutrin XL
4 CommentsBy Ed Silverman // October 25th, 2007 // 5:31 pm
Why? The issue appears to be generic equivalency. Some people reported having headaches, anxiety and other ailments. And the agency is also reviewing the scientific formulation of the drug, called Budeprion XL, after a consumer-product testing group published results that showed key differences from the original drug, according to the Associated Press.
The tests, conducted by ConsumerLab.com, came after Budeprion XL users earlier this year began complaining that the drug caused severe headaches, digestive problems, anxiety, tremors, and insomnia. Another Web site, peoplespharmacy.com, reported that more than 250 people had complained about the drug. Budeprion XL is made by Impax Laboratories and sold by Teva Pharmaceutical. Impax declined to comment and Teva representatives did not immediately return calls to the AP.
In ConsumerLab’s test, the once-daily Budeprion XL released 34 percent of its active ingredient after two hours, compared to 8 percent for the original drug. “It’s been an eye-opener for everyone,” Tod Cooperman, president of ConsumerLab.com, tells the AP. “It makes you question whether generics are always going to be equivalent to the original product. If these things are releasing at such different rates, it’s hard to believe they’d be acting the same way in your body.” The FDA, however, couldn’t provide data to support ConsumerLab’s findings.
“FDA cannot offer any examples where generics have been shown to not perform as expected. FDA has many years of experience in the review of generic drugs and has great confidence in the quality and equivalence of generic drug products,” the agency told the AP.
In 2005, Canadian firm Biovail petitioned the FDA to require rigorous testing on generic versions of Wellbutrin XL before being approved. While some saw it as a delay tactic, the drugmaker said it was to protect patients from serious risks, such as seizures. The FDA approved the first generic versions of Wellbutrin XL in 2006.
M.Tunney
Why does the Biovail Wellbutrin XL 150mg and 300mg tablets odered from CanadaDrugs.com differ from the Wellbutrin XL tablets in the US? The US tabs have Wellbutrin XL printed on one side and the Bioval Wellbutrin XL tabs have “WXL 300/150″ printed on it? They are the exact same drug, correct, and not generic? Does Glaxo partner with Biovail?
B. Shaine
From what’s available on the web, apparently they do partner. Search “biovali glaxo”
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Biovail and GlaxoSmithKline Sign Licensing Agreements for Once Daily Formulation of Wellbutrin and Distribution Rights for Zovirax Ointment & Cream
TORONTO & LONDON–(BW HealthWire)–Oct. 29, 2001–Biovail Corporation (NYSE, TSE:BVF) and GlaxoSmithKline plc (GSK) today announced that Biovail has licensed to GSK a novel controlled-release, once-daily formulation of bupropion hydrochloride (HCI) for sales and distribution on a world-wide basis.
Mary
I take Wellbutrin (now called Budeprion) and I have lost almost 16lbs. It has helped me GREATLY! I’m also exercising a lot more because of the energy I’m getting from it. I can concentrate better. I am more aware of things too. I’m overweight and this has helped me in that area sooo much. :)
Andrew Craig
Taking Budeprion is worse than dropping the medication all together in my opinion. I tried it for 10 days; had jitters; irritability, and found sleeping to be very difficult. I was definitely not myself. The pharmacies seem to have dropped the generic bupropion in favor of Budeprion; because of the cost. This is a shame.