Thyroid Drug Faces FDA Deadline
Widely used Synthroid looking for renewed approval
The popular thyroid drug Synthroid, which has been sold for years, faces an August deadline to gain approval from the Food and Drug Administration (FDA), says this wire service story in the Los Angeles Times.
The FDA turned down a request that the drug be classified "generally regarded as safe and effective," the story says.
Abbott Laboratories, which acquired Synthroid's rights earlier this year, says it plans to seek approval for the medication as a new drug. The FDA says it is proceeding cautiously on the drug, which has been sold since the 1960s, because of changes in its formula.
The drug likely will stay on the market during the approval process, which can take 10 months or more, the story says.