It is official; FDA is withdrawing approval of all NDAs and ANDAs for propoxyphene. Propoxyphene formulations which have been in the market for the past 50 years either, as the sole active ingredient or as a combination with other non-opioid pain medications can no longer be delivered or introduced for delivery in the market. The drug has been a Schedule IV Controlled Substance since mid 1970s, but in in January 2009, an FDA advisory committee voted against the continued marketing of propoxyphene products. Even though the FDA allowed marketing of propoxyphene with a boxed warning in its label, new clinical data obtained thereafter, suggested that patient receiving propoxyphene are at risk of potentially serious or even fatal heart rhythm abnormalities. Today FDA announced its conclusion "that the risks of propoxyphene outweigh its benefits as a pain reliever." As such, introduction or delivery for introduction of these products into interstate commerce without an approved application is illegal and subject to regulatory action.
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