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Archive for the 'Drug testing' Category

White Plains firm critical of FDA’s review of drug

April
18

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 agency’s review “inadequate.”

White Plains-based ConsumerLab.com and The People’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,  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 “safe and effective.” The agency also said the generic version was equivalent, and therefore interchangeable with, Wellbutrin XL 300.

Calling the FDA’s findings disappointing, ConsumerLab.com and The People’s Lab said there was no evidence that the FDA evaluated the generic drug fully.

“For the FDA to say that it has reviewed the safety and efficacy of this product is not correct,” said Dr. Tod Cooperman, president of ConsumerLab.com.

“The FDA is misleading the public by publishing a positive review which actually provides no data for the 300 milligram product – the strength about which people are complaining,” said Joe Graedon of The People’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.

Posted by David Schepp on Friday, April 18th, 2008 at 4:43 pm | del.icio.us Digg
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Emisphere drug proves positive in dog studies

April
16

Emisphere Technologies Inc. reported today that studies involving dogs have provided additional evidence that a technology the company is developing enhances absorption of oral vitamin B12 supplements.

The results confirm an earlier report of effectiveness in studies conducted in rats using Emisphere’s Eligen technology, which reportedly improves absorption of orally administered drugs.

About 40 million Americans undergo annual B12 injections to treat a variety of serious medical conditions. An addition 5 million people yearly consume more than 600 million B12 tablets in various strengths as nutritional supplements, Emisphere said.

Posted by David Schepp on Wednesday, April 16th, 2008 at 2:55 pm | del.icio.us Digg
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