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The planned withdrawal of Budeprion XL 300 mg is the result of studies conducted by the company and FDA aimed at addressing reports of reduced efficacy from patients who were switched to generic forms of Wellbutrin XL 300 mg made more than 5 years ago.
The bioequivalence problem was confirmed in an FDA-sponsored study conducted in 2010, comparing the bioequivalence of the Impax/Teva product to Wellbutrin XL 300 mg in 24 healthy adults, which determined that the generic tablets "fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg," according to the statement.
The government also charged that GSK paid physicians to promote off-label uses of Wellbutrin ranging from weight loss to the treatment of sexual dysfunction.
Pinsky, who in 1999 was one of the co-hosts of radio sex-advice show "Loveline," used his platform to discuss an affinity for Wellbutrin, according to documents disclosed this week by the U.
Annual sales of Wellbutrin SR 100mg and 200mg and the generic equivalent in that strength in the United States was USD115 million for the 12 months ending March 2010 according to IMS Health data.
GlaxoSmithKline PLC introduced Wellbutrin XL, an extended-release form of the drug that could be taken just once a day.
Empatic combines the antidepressant Wellbutrin, known generically as bupropion, with anti-seizure drug zonisamide, which can cause birth defects and altered cognitive function.
GlaxoSmithKline's unique dual-acting treatment option for major depressive episodes, Wellbutrin, is currently available as a once daily extended-release tablet, Wellbutrin XL.