plans to phase out any levothyroxine products that don't have an approved NDA
The FDA is proceeding with plans to phase out any levothyroxine products that don't have an approved NDA.
Companies that don't submit an NDA by August 14th will have to stop making it...and companies still awaiting approval will be required to reduce production every 3 months until approved.
So far Unithroid and Levoxyl are the only approved products.
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