The American Thyroid Association, The Endocrine Society, and ThyCa: Thyroid Cancer Survivors' Association are urging that the Food and Drug Administration (FDA) maintain the uninterrupted availability of Synthroid and other currently marketed thyroid hormone (thyroxine) products to the 13 million U.S. patients who rely on them every day for life to treat hypothyroidism, thyroid cancer, and other thyroid conditions.
Abbott's press release indicating that it will be submitting a New Drug Application for Synthroid.
The American Association of Clinical Endocrinologists issues press release objecting to the recommendation from the National Organization of Women (NOW) and the Gray Panthers that the Food and Drug Administration (FDA) withdraw Synthroid from the market.
The Gray Panthers sent a letter to Abbott asking the company to respond to FDA concerns regarding the safety and effectiveness of Synthroid, concluding: "Unless we receive satisfactory answers to the questions posed in this letter, we believe your product should be removed from the market."
The FDA has issued its approval for Levoxyl, manufactured by King. Now, thyroid patients have two FDA-approved levothyroxine drugs, at two very different prices and availabilities, to choose from. In the meantime, the top-selling levothyroxine drug, Synthroid, has still not filed for or received FDA approval.
Group threatens class action suit against Synthroid if the drug is not withdrawn from market. The strategy is intended to raise the financial stakes for drug manufacturers that engage in anti-competitive or anti-consumer behavior in order to avoid competition.
Watson press release discussing Unithroid's status as only approved levothyroxine drug.
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.
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.
Is it Synthroid, Unithroid, Armour, Thyrolar, Cytomel, or something else? The answer might surprise you.
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.
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?
Unithroid is still the only FDA-approved levothyroxine product. But can you get a prescription filled easily? And if so, where can you get it?
Knoll Pharmaceutical, manufacturer of Synthroid, to be sold to Abbott Laboratories.
Product samples given to doctors are mislabeled, and patients may be receiving 100 mcg pills labeled as 200 mcg. Find out if you have any of the mislabeled product!
