From Mary Shomon Your Thyroid Guide
FDA Letter to Knoll Pharmaceuticals Refusing Special Status for Synthroid, April 26, 2001
April 26, 2001
The FDA has sent a scathing letter to Knoll Pharmaceuticals, denying their request for "Generally Recognized as Safe and Effective" status, and outlining a host of stability, potency and manufacturing problems that the FDA claims have made Synthroid unreliable and subpotent. You can download a copy of the letter from the FDA to Knoll Pharmaceuticals in PDF format. (Information, instructions, and a free copy of Adobe Acrobat Reader, which will enable you to read and print out PDF files, are all available at Adobe's website.)
Read about the letter, and what it means for Synthroid, in Synthroid Has a Long History of Problems, Says FDA
In response to this denial, Abbott Laboratories is being forced to submit a New Drug Application for Synthroid. For more information, read: Abbott Laboratories to Submit New Drug Application for Synthroid
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