| Synthroid Receives FDA Approval | |
from Mary J. Shomon
July 24, 2002 -- In the conclusion to a saga that goes back five years, it was announced today that the U.S. Food and Drug Administration (FDA) has approved the synthetic thyroid hormone replacement drug Synthroid®, which is manufacturered by Chicago-based Abbott Laboratories.
Synthroid, is one of the top five drugs sold in the U.S., and millions of people who suffer from thyroid disorders including hypothyroidism, goiter and thyroid nodules take this thyroid hormone replacement drug.
Speaking to Mary Shomon on July 24, 2002, Abbott spokesperson Jennifer Smoter said: “We very pleased and excited and very happy this is cleared up for patients.”
According to Smoter, there was no reformulation on the product for FDA approval. Says Smoter:
It’s the same size, the same colors, and same shape. The only difference is that, for easier identification, where the pills used to say "Flint," they now say "Synthroid.”
Smoter also indicated that patients should continue to take the newly-approved Synthroid in the same manner as they always have.
Synthroid, which has been the market leader in levothyroxine drugs, is the fourth levothyroxine drug to receive FDA approval. Jerome Stevens’ Unithroid received approval in August of 2000, King’s Levoxyl was approved May of 2001, and Mova’s Levo-T was approved in March of 2002.
In 1997, the FDA called for all levothyroxine drugs to go through the new drug application (NDA) process, after it was determined that Synthroid and other levothyroxine drugs had significant stability and potency problems. Synthroid and the other levothyroxine drugs had never gone through FDA approval; they were grandfathered in under claims that they were in the same class of drugs as the natural thyroid drugs such as Armour Thyroid, which existed before the FDA was instituted.
Synthroid initially claimed that it was exempt from the approvals process, attempting to obtain Generally Recognized as Safe and Effective (GRAS/E) status from the FDA, but was rejected, on the basis of concerns about the product quality. Synthroid later asked for and received extensions to the submission process, and today's approval comes almost two years after the FDA's initial August 2000 deadline.
The FDA’s call for NDA for levothyroxine products came in the months after a class-action lawsuit was filed against Synthroid’s manufacturers in May of 1997, claiming that the company had suppressed research findings that showed that Synthroid was bioequivalent and not superior to its competitors. While the company settled on that class action lawsuit, the settlement is still not finalized and no payments have yet been made to the patients who are part of the suit.
With today’s FDA approval, the FDA’s 2001 punitive requirements that Abbott step down production in late 2001 and 2002 -- until the product received approval or was taken off the market -- are now lifted, and the company will be able to move back into full production and its characteristically heavy marketing of the drug.
In a press release, Jeffrey Leiden, M.D., Ph.D., Abbott's chief scientific officer and president, Global Pharmaceuticals, had this to say:
Today’s FDA approval is good news for the millions of Americans who rely on Synthroid every day to control their thyroid disease.
More Information
.
