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FDA Will Not Immediately Withdraw Unapproved Thyroid Drugs

© Keri

In guidelines issued July 12, 2001, the FDA explained how the agency would handle unapproved levothyroxine sodium products after the August 14 application deadline. Since there are now two approved options, the FDA has issued the following guidance on the transition of patients from unapproved to approved products.

"Because there is no public health emergency that requires an immediate switch to the approved drugs, GDA has established a gradual phase out of distribution of the unapproved products to allow manufacturers of approved products to scale up to meet demand and to allow adequate time for patients and health care providers to make an orderly transition from unapproved to approved products." (1)

According to RxList.com Top 200, the top three levothyroxine prescription drugs are Synthroid, Levoxyl (manufactured by Jones Pharma) and Levothroid. Of these three, Levoxyl has been approved by the FDA. Forest Pharmaceuticals manufacturers of Levothroid submitted an NDA in October of last year.

Abbott Laboratories has declared its intent to submit the required NDA for Synthroid by the deadline. According to Dr. David Pizzuti, M.D., Vice President, Global Medical Affairs, at Abbott, "Abbott is confident that the Synthroid NDA will demonstrate safety and efficacy and will be approved. Therefore, patients can be assured of a continued adequate supply of Synthroid while the FDA reviews the NDA for this product." (2)

While Unithroid [Watson Pharmaceuticals] did not make the top 3, it was the first levothyroxine to be approved by the FDA. Watson is fast pursuing its share of this lucrative market.

SPAN Coalition has praised the FDA for its response that requires non-approved drugs to be phased out of the market. In a media release, Tim Fuller, Executive Director of the Gray Panthers, stated, "The FDA agrees with consumers that Synthroid should be removed from the market. The question is no longer if it will happen but how long will patients tolerate uncertainty about Synthroid and how long will doctors tolerate risks associated with prescribing unstable and unapproved medicine."(3)

On August 14, the FDA will divide the non-approved levothyroxine products into two categories: those who have submitted an NDA (new drug application) and are under review and those that have not submitted an NDA. Under the phase out plan, those with an NDA pending should reduce distribution incrementally over the next two years. By August 14, 2003, all unapproved distribution must cease. Specifics of the plan that would significantly reduce the availability of non-approved drugs can be found in Guidance for Industry Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications.

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