Synthroid may be removed from market

The US Food and Drug Administration has told Abbott Laboratories thatits hypothyroidism treatment Synthroid (levothyroxine sodium) has "a history of problems" and cannot be recognized as "safe and effective," according to the Wall Street Journal. The decision follows a request by the FDA in 1997 that all manufacturers of levoxythyroxine should file New Drug Applications, due to stability problems (Marketletters passim).

Abbott's 40-year-old drug has never been officially approved for use by the agency and will now be subject to regulatory action, which could lead to the removal of the drug from the market as early as August, notes the Wall Street Journal.

Abbott, which recently acquired BASF Pharma, the maker of Synthroid (Marketletter December 1 and 8, 2000), has said it will still submit an application to the FDA detailing the drug's safety and efficacy and is confident that the agency will allow the drug to stay on the market. The FDA, however, noted that there are already two other drugs in Synthroid's class which have been approved, Jerome Stevens Pharmaceuticals' Unithroid (Marketletter September 4, 2000) and King Pharmaceuticals' Levoxyl (Marketletter June 4), which could fill any void.