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01-06-2011 01:20 PM
FYI. From a release today by the FDA and sent out via enewsletters:
The FDA has requested that generic companies marketing propoxyphene-containing drugs remove the products from the U.S. market after new clinical data showed brand versions of the drugs increased the risk of potentially serious or fatal heart rhythm abnormalities.
The brand versions of the drugs, marketed by Xanodyne Pharmaceuticals as the prescription opioid painkillers Darvon and Darvocet, have already been withdrawn in the UK due to negligible effectiveness and a high overdose risk.
The products will now be removed from the U.S. market as well following a request from the FDA, Gerald Dal Pan, director of the FDA?s Office of Surveillance and Epidemiology, said in a conference call last month.
Read the entire article (and more) in the current issue of Generic Line.
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