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FDA probes thyroid drug
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June 1, 2001: 4:48 p.m. ET
Agency denies Abbott Labs petition to clear Synthroid as 'safe and effective'
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NEW YORK (CNNfn) - The U.S. Food and Drug Administration has told Abbott Laboratories that its thyroid drug Synthroid could be taken off the market, a culmination of years of regulatory disputes over the medication.
The agency's newly raised concerns about the 40-year-old drug – which has never been officially approved by the FDA – raises the possibility that the drug could face regulatory action beginning as early as August.
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 CNNfn's Chris Huntington with more on the thyroid drug Synthroid. |
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Last month, the FDA denied an Abbott Labs petition that Synthroid be cleared as "safe and effective."
Abbott (ABT: Research, Estimates), in a move to bypass the formal approval process, had recently submitted a "Citizens' Petition" to the FDA making the case that Synthroid had been used safely for decades and thus deserved to be "grand-fathered" in, which was denied by the FDA.
According to the FDA, Abbott needs to submit an application by August 14 to get the agency's formal approval to continue marketing Synthroid.
Abbott issued a statement Friday afternoon stating Synthroid is "a safe and effective treatment for hypothyroidism."
The company said it will be submitting its application, has notified the FDA of its intent and "is working cooperatively with the agency to meet the filing timeframes."
Abbott acquired Synthroid earlier this year when it bought its maker, Knoll Pharmaceuticals, from Germany's BASF.
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Some of Synthroid's competitors could stand to benefit from Abbott's imbroglio with the FDA. King Pharmaceuticals Inc. (KG: Research, Estimates), which recently received FDA approval for its thyroid drug, Levoxyl, raised its earnings guidance Friday for 2002 to between $1.52 and $1.60 per share from an earlier $1.40-to-$1.48 per-share estimate. The company also raised its 2002 revenue estimate to between $1.0 billion and $1.1 billion from a previous range of $950 million-to-$1.05 billion.
Shares of King gained $3.33 to $53.91 on the New York Stock Exchange, while Abbott fell 36 cents to $51.62.
King's Levoxyl accounts for about 25 percent of the U.S. market compared with Synthroid's 60 percent, The Wall Street Journal quoted a King spokesman as saying. 
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