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www.fdanews.com/articles/176304-fda-withdraws-approval-for-drugs-due-to-inefficiency

FDA Withdraws Approval for Drugs Due to Inefficiency

April 21, 2016

The FDA is yanking approval for 14 cholesterol drugs after concluding that the active ingredients have little effect.

Based on the results of several large-scale clinical trials, the agency withdrew approval for four branded and 10 generic drugs containing either niacin extended-release or fenofibric acid delayed-release.

The withdrawal was supported by the affected companies, including AbbVie — maker of Advicor, Niaspan, Trilipix and Simcor — and generic drugmakers Lupin, Mylan, Sun Pharma, Barr and Anchen Pharmaceuticals.

 

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