Synthroid Denied GRAS/E Status By FDA

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May 25, 2001

In a letter dated 26 April 2001, the US Food and Drug Administration (FDA) denied citizen's petition from Knoll for generally regarded safe and effective (GRAS/E) status for Synthroid. Abbott Laboratories recently acquired Knoll Pharmaceutical Company, the producer of Synthroid, from BASF Pharma.

In 1997, the FDA announced that all oral forms of levothyroxine sodium (the generic name for synthetic T4 replacement) were new drugs and required the manufacturers to submit applications for approval. The original deadline for submission was August 2000 but was extended to August 2001 at the request of Abbott/Knoll. Drugs not approved by the deadline may be subject to regulatory action.

The FDA issued this notice partially due to the long history of problems with stability, potency and manufacturing issues with oral forms of levothyroxine. The notice was issued to all manufacturers of this drug.

The FDA denied Knoll's petition based on several issues. According to the letter, the composition of Synthroid has been changed at least 4 times since 1981. Synthroid has a history of problems with stability and potency. Knoll has been sited for manufacturing issues related to the production of Synthroid. The FDA noted that the effects of changes to the formulation and low potency problems directly affected patients, causing them to experience symptoms of hypo- or hyperthyroidism.

In a press release issued by Abbott Laboratories, it was announced that Abbott will submit a New Drug Application to ensure that Synthroid continues to be available for patients. Abbott's Knoll unit estimates that the drug will have sales of $450 million this year.

So far, only one manufacturer, Jerome Stevens Pharmaceuticals, has applied for and received FDA approval for levothyroxine marketed as Unithroid, formerly Thyrox.

For more information:

FDA response to Knoll Pharmaceutical Company

Abbott Says It Will Ask FDA to Formally Approve Synthroid Drug

Abbott Laboratories to Submit New Drug Application for Synthroid(R)(levothyroxine sodium, USP)

Federal Register: August 14, 1997 (Volume 62, Number 157)

FDA Approval Page - Unithroid

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