Federal Register Proposed rule/Notice: FDA is withdrawing approval of 8 NDAs and 46 ANDAs for prescription pain medications containing propoxyphene. The holders of these applications have agreed in writing to permit the agency to withdraw approval of the applications and have waived their opportunity for a hearing. In 2010, after receiving new clinical data showing that when propoxyphene is taken at therapeutic doses, the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities, and other information including new epidemiological data, FDA concluded that the risks of propoxyphene outweigh its benefits as a pain reliever. To view this notice, click here.