January 10, 2023
The D.C. Circuit affirmed Tuesday the U.S. Food and Drug Administration's win in Sandoz Inc.'s lawsuit challenging the agency's decision to give rival Sanofi exclusivity to its multiple sclerosis drug, Aubagio, rejecting Sandoz's claim that the FDA already approved the drug's active ingredient as an impurity in another drug.
November 07, 2022
The U.S. Food and Drug Administration warned the D.C. Circuit on Monday that the court risked upending the way the agency awards exclusivity to drugs and provides incentives to create new ones if it sides with Sandoz Inc. in a dispute over the agency's decision to give exclusivity to Sanofi's multiple sclerosis drug, Aubagio.
October 12, 2022
Novartis unit Sandoz is continuing its fight against the U.S. Food and Drug Administration's decision to give exclusivity to a Sanofi multiple sclerosis drug, saying at the D.C. Circuit that the agency's decision was "legally unsupportable."