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FDA review finds generic Wellbutrin safe, effective


Federal regulators said Wednesday Teva Pharmaceutical's generic version of a popular antidepressant is safe and effective, despite a spate of recent consumer complaints.

The Food and Drug Administration agreed to review Teva's version of Wellbutrin after dozens of patients reported their depression came back after they switched from the original drug, made by GlaxoSmithKline PLC. Some patients said they also experienced headaches, anxiety and other side effects.

In a report posted online, FDA concluded the reoccurance of depression and other side effects are typical of patients taking antidepressants. Regulators pointed out that a study of another antidepressant showed 20 percent of patients relapsed into depression at least once after six months on the drug.

FDA detected slight differences between Teva's formulation and the original, but said they were small enough to be inconsequential.

Shares Israel-based Teva Pharmaceutical Industries Ltd. rose 54 cents Wednesday to $46.55. Shares of London-based GlaxoSmithKline PLC rose 40 cents to $42.61.

Copyright 2008 AP Features
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Author:Staff
Publication:AP Features
Date:Apr 16, 2008
Words:155
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