The FDS told manufacturers of unapproved oral levothyroxine sodium products, used to treat thyroid conditions, to limit distribution starting Aug. 14.
According to the FDA's July 12 guidance, Which was addressed to makers of unapproved oral levothyroxine sodium with new drug applications still pending on Aug. 14, the companies should reduce distribution on an incremental, monthly basis. All distribution of unapproved levothyroxine sodium must stop by Aug. 14, 2003.
Only two approved levothyroxine sodium products will be considered "approved" by the Aug. 114 deadline--Unithroid by Jerome Stevens Pharmaceuticals and Levoxyl by Jones Pharma. There is no immediate public health concern regarding Synthroid, so Abbott Laboratories' popular product will remain on the market while its NDA is reviewed. However, the FDA said patients and healthcare providers should "make an orderly transition from unapproved to approved products." U.S. sales of Synthroid were an estimated $425 million last year among the drug's 8 million patients.
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