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Abbott Laboratories Forced to Submit New Drug Application for Synthroid |
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Company Lost Bid for Special Status, Forced to Apply in Order to Remain on Market After August, 2001
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Join the Discussion
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"I, too, have a moral/ethical problem with Knoll, and since Synthroid didn't seem to much of anything at all for me, I switched to Unithroid as soon as I could - I started on it around the end of October, 2000, and it was a FABULOUS move!"
LauraG
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by Mary J. Shomon
April 30, 2001 -- According to a press release issued on April 30, 2001 by Abbott Laboratories, which recently acquired the company that manufactures Synthroid, a new drug application (NDA) will be filed for the Synthroid product.
Knoll had been fighting against a 1997 ruling by the United States Food and Drug Administration (FDA) which called for all manufacturers of levothyroxine sodium products to either submit an NDA, or to file a citizen petition to show that their products are not new drugs, and therefore do not require an NDA. Knoll filed a citizen petition in 1997 requesting that FDA acknowledge that Synthroid is not a new drug, and is not subject to the requirements of an NDA. In addition to filing the citizen's petition, Knoll managed to get the original cutoff deadline of August 2000 extended a year, due to numerous Freedom of Information Act (FOIA) requests, and bureaucratic requests that appeared designed to stall the NDA process.
Abbott's decision to submit an NDA follows a response from the FDA that the citizen petition was not approved.
The FDA's decision is a stunning defeat for Knoll, a division of BASF Pharma, which was recently acquired by Abbott. Knoll has apparently been attempting to bypass the FDA's NDA process by getting the drug approved via the "Generally Recognized as Safe and Effective" status. This is the process that was thwarted by the rejection of the citizen petition.
This move comes almost eight months after the August 2000 approval of a levothyroxine product by the FDA. Unithroid, manufactured by Jerome Stevens, received NDA approval is now the FDA's reference drug for levothyroxine.
For a chronological history of othe FDA NDA process and the Synthroid situation, see the following articles:
September, 1997 - Synthroid and other Levothyroxine Drugs Have Significant Stability and Potency Problems -- Government finds significant stability, potency and dosage strength problems with levothyroxine sodium products such as Synthroid and other brandname and generic thyroid hormone drugs. Find out about the potential serious health consequences you face.
August, 2000 -- Food and Drug Administration Approves Unithroid -- First "New Drug Application" for thyroid drug levothyroxine sodium is approved.
September, 2000 -- Should You Switch to Unithroid? -- Currently, Unithroid is the only FDA-approved levothyroxine thyroid drug on the market. Would you feel better if you switched to it from other brands like Synthroid?
February, 2001 -- Synthroid Still Lacks Approval Necessary to Remain Legally on the Market After August 14, 2001 -- Without an approved new drug application from the FDA, or a change in status, Synthroid will not longer be legal to sell after August 14, 2001. What thyroid drugs ARE approved by the FDA at present, and what will happen in August if Synthroid is NOT approved?
March, 2001 -- What is Synthroid Hiding?-- If Synthroid is safe and effective, why won't it apply for FDA approval like its competitors? The clock is ticking, and as the deadline approaches, rather than applying for FDA approval, Synthroid's manufacturers seem more preoccuped with sending marketing to doctors and pharmacists...See the actual letter they are distributing, and find out what questions YOU should be asking.
April 26, 2001 -- Synthroid Has a Long History of Problems, Says FDA, in Denial Letter -- In a scathing letter to Knoll Pharmaceuticals, the FDA has officially denied their request for various approvals to bypass new drug application, illustrating how the top-selling thyroid drug has not been reliably potent and stable for years.
April 30, 2001 -- Abbott Laboratories to Submit New Drug Application for Synthroid -- After failing to bypass the new drug application (NDA) process by applying for "Generally Recognized as Safe and Effective Status," Synthroid's manufacturer is forced to apply for an NDA in order to remain available on the market after August, 2001.
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