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FDA Plans to Phase Out Unapproved Thyroid Products.
ROCKVILLE, MD. -- The Food and Drug Administration has issued details about how it plans to phase out distribution of synthetic thyroid replacement products that were not being formally reviewed by the agency as of Aug. 14.
The FDA set Aug. 14 as the deadline for manufacturers of all marketed levothyroxine products to file new drug applications (NDAs). This requirement, first announced in 1997, was a response to a history of stability and potency problems with orally administered levothyroxine products. Such products never underwent the full FDA approval and review process because they were available before that process was established in 1962.
The FDA has already approved two products under the requirement. Levoxyl, manufactured by King Pharmaceuticals, was approved in May 2001. Unithroid, manufactured by Jerome Stevens Pharmaceuticals Inc., was approved in August 2000. Approval establishes that the FDA considers the product effective and in compliance with standards for manufacturing, purity potency, and stability.
Nearly 2 weeks before the Aug. 15 deadline, Abbott Laboratories Inc. filed an NDA for Synthroid, the top-selling thyroid replacement product. In a statement, Dr. David Pizzuti, Abbott's vice president for global medical affairs in Abbott Park, Ill., said that there was a sufficient supply of Synthroid on the market and that patients can be assured of continued access to Synthroid" while the FDA reviews the application.
Still, the company will be required to gradually reduce distribution of the drug, as mandated by the FDA. Manufacturers of unapproved ...
- Synthroid enters FDA's new-drug process after 46 years of sales.(The Dallas...
- Newspaper article from: Knight Ridder/Tribune News Service Jacobson, Sherry August 13, 2001 700+ words
...new drug application to the FDA for Synthroid. It will take 10 months to...available by August 2003. If Synthroid wins FDA approval a year from now, supplies...Association, have petitioned the FDA to let Synthroid sales continue. Abbott is hoping...
- Abbott Laboratories' SYNTHROID(R) (Levothyroxine Sodium Tablets, USP) Confirmed...
- Press release article from: PR Newswire July 24, 2002 700+ words
...their thyroid health. Formal approval by FDA of SYNTHROID validates its safety and efficacy. With FDA approval, Abbott is now free to meet...Are Not Therapeutically Equivalent to SYNTHROID The FDA publication, Approved Drug Products with...
- Abbott Laboratories Submits New Drug Application for Synthroid(R)...
- Press release article from: PR Newswire August 1, 2001 700+ words
...2001 guidance, the FDA allowed Synthroid to remain on the market...clinical experience of Synthroid. On April 26, the FDA denied Knoll's petition...now well controlled on Synthroid remain on the drug. The FDA publication, Approved...
- Gray Panthers Invites Abbott Laboratories to Public Forum On FDA's Synthroid...
- Press release article from: PR Newswire June 15, 2001 700+ words
...please address the FDA finding that the formula for Synthroid "has been changed...recalled, and to the FDA's determination that "Synthroid has not been reliably...guided by the recent FDA statements about Synthroid and Abbott's complete...
- FDA Approves Abbott Laboratories' Thyroid Drug, Synthroid.
- Newspaper article from: Knight Ridder/Tribune Business News July 25, 2002 700+ words
...and regulations. But the FDA decided to review Synthroid and other thyroid medications...safe and potent. Until Synthroid passed FDA approval, patients weren...allowed to continue selling Synthroid while under FDA review, the agency required...
- Consumer Claims Against Synthroid(R) Vindicated by FDA, According to Gray...
- Press release article from: PR Newswire July 12, 2001 700+ words
...Laboratories to respond to FDA concerns about its Synthroid thyroid medication today...effective alternatives. The FDA stated in April that "Synthroid cannot be generally...history of problems." FDA indicated in 1997 that Synthroid would need to be removed...
- FDA Guidance on Levothyroxine Sodium Products Assures Synthroid(R)...
- Press release article from: PR Newswire July 12, 2001 700+ words
...Abbott Will Submit NDA for Synthroid in Advance of FDA Guideline; Confident That...Abbott will be submitting for Synthroid. The FDA's decision to keep Synthroid...continued adequate supply of Synthroid while the FDA reviews the NDA for this...
- Gray Panthers Challenge Abbott Labs and American Thyroid Association To Answer...
- Press release article from: PR Newswire June 1, 2001 700+ words
...NDA) process. Synthroid has been on the...years without FDA approval. The...cannot meet the FDA's safety standards, then Synthroid should be removed...products. "The FDA clearly stated...Application for Synthroid must be approved...