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January 13, 2023

D.C. Circuit Court Rules Impurities Not Included in FDA Drug Approvals

On Tuesday, January 10, 2023, a unanimous three-judge panel of the U.S. Court of Appeals for the D.C. Circuit upheld the district court judge’s ruling granting the FDA summary judgment against Sandoz Inc.. The case resolved Sandoz’s challenge that the active ingredient, teriflunomide, in Sanofi’s multiple sclerosis drug, Aubagio, was already approved as an impurity in another rheumatoid arthritis drug, Arava. The Circuit Court held that 

  • known impurities have not been approved within a meaning of the Federal Food, Drug, and Cosmetic Act, and 
  • “a new drug that employs a known impurity as its active ingredient is eligible for new chemical entity exclusivity” under the Hatch-Waxman Act,.which allows a drug to have new chemical entity exclusivity if no active ingredient of the drug has been previously approved by the FDA.  
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