Posted by Phillipa on July 26, 2007, at 22:39:41
In reply to This Year Sometime Synthroid Brand Will Be Generic, posted by Phillipa on July 26, 2007, at 22:22:57
Here's one. Phillipa
Synthroid Receives FDA Approval
From Mary Shomon,
Your Guide to Thyroid Disease.
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Top-Selling Thyroid Drug Required Nearly Five Years to Meet FDA's Standards
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 are 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.
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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. It was rejected on the basis of FDA concerns about product quality. Synthroid later asked for and received extensions to the submiss ion process, and today's approval comes almost two
poster:Phillipa
thread:772252
URL: http://www.dr-bob.org/babble/20070719/msgs/772258.html