Teva’s Generic Antidepressant Deemed Ineffective by FDA
The shipping of a generic antidepressant — Budeprion XL 300 — was halted by Teva Pharmaceuticals after its drug was found to be ineffective in tests by regulators.
The Associated Press (AP) reports that the U.S. Food and Drug Administration (FDA) found that Budeprion XL 300, which is prescribed to treat depression, anxiety, and symptoms of nicotine withdrawal, releases the active ingredient faster than the original brand-name drug WellbutrinXL 300 on which it is based.
The FDA asked Teva to withdraw the drug since all generic drugs approved by the agency must be chemically the same as their brand-name counterparts.
The FDA’s recent move reverses its 2008 position that the drugs are fundamentally the same, according to the AP. Justifying the new findings, the FDA stated that earlier it had conducted tests on the 150 mg version of Budeprion and assumed the 300 mg version would perform similarly.
However, the AP reports that after receiving consumer complaints about the adverse effects of the 300 mg form of the generic antidepressant drug, the FDA decided to perform more tests, which led it to change its earlier position.
Actavis, Anchen, Mylan, and Watson are the other four other generic drugmakers who market the 300 mg variants of bupropion—the chemical name for Wellbutrin. The AP writes that the FDA has not tested their equivalents of Wellbutrin but has asked them to conduct studies and submit reports by March 2013.
If you or someone you know has been harmed by a dangerous drug, contact Sokolove Law today for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you.