October 5, 2012
The FDA has pulled Teva Pharmaceuticals' (NYSE: TEVA ) generic version of antidepressant drug Wellbutrin from the market. The issue is not one of safety, but efficacy, as Teva's 300mg generic fails to meet the bioequivalence of the original branded version, which is marketed by Valent Pharamaceuticals (NYSE: VRX ) . The 150mg dosage of the drug performs as required and will not be affected.
If instances like this lead the FDA to reassess the generic approval process, it would be good news for branded pharma, in general, and bad news for generics. Raising the hurdle for generic bioequivalence could mean discount-drug cost spikes down the line. For the full story and Fool.com analyst Brenton Flynn's take on the issue, check out the video below.
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