ARTICLE
30 September 2014

FDA Withdraws Approval From Three ANDAs For Products Containing Propoxyphene

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FDA withdrew approval of three abbreviated new drug applications ("ANDAs") for products containing propoxyphene.
United States Food, Drugs, Healthcare, Life Sciences

In the September 12, 2014 Federal Register, FDA withdrew approval of three abbreviated new drug applications ("ANDAs") for products containing propoxyphene. FDA found the products are no longer shown to be safe due to risks of potentially serious and even fatal heart rhythm abnormalities. The holders of these ANDAs waived their opportunity for a hearing. Effective September 12, 2014.

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