Two consumer-advocacy organizations are criticizing a U.S. Food and Drug Administration investigation into a generic version of a popular, once-daily dose antidepressant, calling the regulatory agencyâ€™s review â€œinadequate.â€
White Plains-based ConsumerLab.com and The Peopleâ€™s Pharmacy, of Durham, N.C., faulted a affirmative determination by the FDA that a generic version of Wellbutrin XL 300, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals,Â because the findings were based on information from a lower dose of the drug.
In reporting its findings this week, the FDA said the generic version, marketed as Budeprion XL 300 milligrams, was â€œsafe and effective.â€ The agency also said the generic version was equivalent, and therefore interchangeable with, Wellbutrin XL 300.
Calling the FDAâ€™s findings disappointing, ConsumerLab.com and The Peopleâ€™s Lab said there was no evidence that the FDA evaluated the generic drug fully.
â€œFor the FDA to say that it has reviewed the safety and efficacy of this product is not correct,â€ said Dr. Tod Cooperman, president of ConsumerLab.com.
â€œThe FDA is misleading the public by publishing a positive review which actually provides no data for the 300 milligram product â€“ the strength about which people are complaining,â€ said Joe Graedon of The Peopleâ€™s Pharmacy (www.peoplespharmacy.com).
The agency undertook its investigation after receiving complaints that patients taking the branded product experienced a loss of effectiveness when switched to the generic pill. Further, patients reported new onset or worsening of side effects.