Posted by Jane D on June 2, 2001, at 22:09:36
In reply to Heard they are taking Synthroid off the market , posted by lissy on June 2, 2001, at 20:19:34
> I heard from someone who saw on the news they are taking synthroid off the market. Has anyone else heard that and know any more info? Does that include the generic form levoxyl (sp?) also?
No. Levoxyl and Unithroid will definately be available. Synthroid may be.
The story is this according to a newspaper article I saw yesterday. Levothyroxine has been around for years and never went through the FDA approval process. There have also been a lot of complaints that the drug wasn't the same strength from batch to batch. Four years ago the FDA told all the makers of levothyroxine that they needed to file a new drug application. They cannot sell it after August 14 without an APPROVED application.
The makers of Levoxyl and Unithroid filed their applications and got them approved. The maker of Synthroid filed a petition that it should be excused from filing the application. This petition got turned down and now, having wasted 4 years, they must scramble to file their application. They are also trying to claim that the application doesn't need to be approved by August 14 just submitted. The FDA disagrees.
I don't know whether the FDA actually would pull Synthroid. One of the other makers was quoted as saying that they could fill any gap but there are millions of people using Synthroid.
poster:Jane D
thread:65205
URL: http://www.dr-bob.org/babble/20010530/msgs/65212.html