FDA orders cutback on Synthroid distribution

The US Food and Drug Administration has told Abbott Laboratories that itwill have to gradually reduce its distribution of Synthroid (levothyroxine sodium), and face a complete phase out within two years, unless it can prove the drug's safety and efficacy. However, the agency has reassured the company that Synthroid can remain on the market while a New Drug Application for the drug is reviewed (see also page 6).

The FDA said in a statement that it had opted for a gradual phase-out because "there is no public health emergency that requires an immediate switch to the approved drugs." The two-year timeframe will allow manufacturers of approved products to scale up to meet demand and help patients and health care providers to make an orderly transition from unapproved to approved products, said the agency.

As previously reported, Abbott has said it will submit an NDA in advance of the agency's required filing date of August 14. There are a number of other unapproved levothyroxine products on the US market, with only two versions - King Pharmaceuticals' Levoxyl and Watson/Jerome Stevens Pharmaceuticals' Unithroid - having successfully gone through the NDA process.