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WASHINGTON (Reuters Health) - In a move partially meant to allay the fears of the millions of Americans taking Synthroid, the US Food and Drug Administration (news - web sites) (FDA) clarified on Thursday that the agency has given makers of the thyroid drug until August 14 to file for approval.
The FDA also said that it does not intend to immediately withdraw any unapproved levothyroxine products currently on the US market, citing the concern that it will take considerable time for patients on the unapproved products to switch to approved ones.
Used by millions of Americans for the treatment of thyroid disease, levothyroxine has been available on the US market for many years without FDA approval. Synthroid is the most commonly prescribed levothyroxine product and the nation's third mostly commonly prescribed medication. It has been on the US market for about 40 years without FDA approval.
The FDA said that it would phase out the unapproved products over a 2-year period if they fail to file for approval by the August deadline or their approval application is denied. In 1997, the FDA announced that every manufacturer of levothyroxine would be required to either file a new drug application (NDA) and/or citizen petition showing that their products are not new drugs. The agency said that it was issuing the rule because it determined that levothyroxine itself could not be generally recognized as a safe and effective treatment.
Although the FDA has since approved two orally administered levothyroxine products, that announcement recently has created considerable difficulty for the agency because of media reports suggesting that the FDA might withdraw Abbott Laboratories' thyroid drug Synthroid, which Abbott acquired in March as a result of its merger with Knoll Pharmaceutical Company.
The media reports were based upon the fact that Knoll Pharmaceutical Company had failed to file an NDA, choosing instead to file a citizen's petition that the FDA subsequently denied in April.
The Abbott Park, Illinois-based drug manufacturer issued immediate praise for the FDA clarification.
``If their medication is switched, patients must be reevaluated and re-tested,'' noted Dr. David Pizzuti, Abbott's vice president for global medical affairs.
Abbott further confirmed that it plans to file an NDA by the agency's August deadline. ``Abbott is confident that the Synthroid NDA will demonstrate safety and efficacy and will be approved,'' Pizzuti said.
But the consumer group Gray Panthers, while praising the FDA clarification, offered a different interpretation of the FDA's guidance. According to the group, which has in the past expressed concerns about Synthroid's safety, the FDA guidance means that Abbott would need to reduce its sales of Synthroid by 55% within a year and terminate sales completely within 2 years.
The group acknowledged that Abbott could resume sales of the product if the company was able ``to demonstrate that Synthroid is stable and of consistent potency.''
The approved levothyroxine products currently include Watson Pharmaceuticals Inc.'s Unithroid and King Pharmaceuticals Inc.'s Levoxyl.
The FDA also said that it does not intend to immediately withdraw any unapproved levothyroxine products currently on the US market, citing the concern that it will take considerable time for patients on the unapproved products to switch to approved ones.
Used by millions of Americans for the treatment of thyroid disease, levothyroxine has been available on the US market for many years without FDA approval. Synthroid is the most commonly prescribed levothyroxine product and the nation's third mostly commonly prescribed medication. It has been on the US market for about 40 years without FDA approval.
The FDA said that it would phase out the unapproved products over a 2-year period if they fail to file for approval by the August deadline or their approval application is denied. In 1997, the FDA announced that every manufacturer of levothyroxine would be required to either file a new drug application (NDA) and/or citizen petition showing that their products are not new drugs. The agency said that it was issuing the rule because it determined that levothyroxine itself could not be generally recognized as a safe and effective treatment.
Although the FDA has since approved two orally administered levothyroxine products, that announcement recently has created considerable difficulty for the agency because of media reports suggesting that the FDA might withdraw Abbott Laboratories' thyroid drug Synthroid, which Abbott acquired in March as a result of its merger with Knoll Pharmaceutical Company.
The media reports were based upon the fact that Knoll Pharmaceutical Company had failed to file an NDA, choosing instead to file a citizen's petition that the FDA subsequently denied in April.
The Abbott Park, Illinois-based drug manufacturer issued immediate praise for the FDA clarification.
``If their medication is switched, patients must be reevaluated and re-tested,'' noted Dr. David Pizzuti, Abbott's vice president for global medical affairs.
Abbott further confirmed that it plans to file an NDA by the agency's August deadline. ``Abbott is confident that the Synthroid NDA will demonstrate safety and efficacy and will be approved,'' Pizzuti said.
But the consumer group Gray Panthers, while praising the FDA clarification, offered a different interpretation of the FDA's guidance. According to the group, which has in the past expressed concerns about Synthroid's safety, the FDA guidance means that Abbott would need to reduce its sales of Synthroid by 55% within a year and terminate sales completely within 2 years.
The group acknowledged that Abbott could resume sales of the product if the company was able ``to demonstrate that Synthroid is stable and of consistent potency.''
The approved levothyroxine products currently include Watson Pharmaceuticals Inc.'s Unithroid and King Pharmaceuticals Inc.'s Levoxyl.
