The Food and Drug Administration has told the makers of Synthroid, the third most frequently prescribed drug in the U.S., that the medicine has a “history of problems” and cannot be recognized as “safe and effective.”The agency’s statements raise the possibility that the 40-year-old drug, which has never been officially approved for use by the FDA, will be subject to regulatory action that could, in the extreme, include removal from the market — a process that could begin as early as August. Synthroid went on the market more than four decades ago and never received formal approval from the FDA.Four years ago, the FDA said that makers of thyroid drugs like Synthroid, known generically as levothyroxine sodium, needed to get FDA approval for the drugs to continue marketing them.Abbott Laboratories, which acquired Synthroid’s maker earlier this year, has said it will submit an application to the FDA detailing the drug’s safety and efficacy and that it is confident the drug will be allowed to stay on the market.
The company said this week that its reading of FDA notices indicated that it had to submit its application to the agency by Aug. 14.But a spokeswoman for the FDA said the regulatory notices the agency has published on Synthroid and its competitors “don’t include a provision” related to simply submitting an application by Aug. 14. The agency has not decided what it would do if the Aug. 14 deadline came and went before the drug received approval.
But it would not rule out asking for the drug’s removal and noted that there are two other approved drugs in Synthroid’s class that could fill any void left by Synthroid.Two other drugs — Levoxyl from King Pharmaceuticals Inc. and Unithroid from Watson Pharmaceuticals Inc. and Jerome Stevens Pharmaceuticals Inc. — have applied for and received approval from the FDA. “We understood that we had to have an approval by Aug. 14, 2001, and we still understand that to be the case,” said James Green, a spokesman for King.
“Of course, we are approved now. We take comfort in that.”
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