Listen to all those generics makers heaving sighs of relief. The FDA has given the thumbs-up to Teva's generic Wellbutrin XL, which has been under investigation since early last year. Patients who'd switched from GlaxoSmithKline's branded form of 300 mg pill to Teva's Budeprion XL 300 mg complained that the drug simply didn't work. They also cited new side effects such as headaches and anxiety. ConsumerLab.com tested the copycat drug, finding that it released 34 percent of its active ingredient within two hours, compared with 8 percent for the branded form.
The FDA, however, concluded that the generic is "bioequivalent and therapeutically equivalent." The agency cited some "small differences" in the two different formulations, but said they're not outside the boundaries for equivalence. Depression does tend to recur, the agency said, so patients may simply have begun a new episode at the same time they switched meds.
But ConsumerLab.com said the FDA cites bioequivalency data not for the 300 mg pill in question but for the 150 mg form. "On top of that, the data they have clearly shows the drug is releasing much faster than the original," said lab chief Tod Cooperman, calling the agency's conclusion "a huge leap of faith."
Teva, on the other hand, says it's pleased with the outcome. And so are other generics makers, no doubt. If the agency had found Teva's version wanting, who knows what new regulations and trials new generics might have had to withstand?
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