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Home » Sandoz Files Suit Against FDA Over Exclusivity for Sanofi MS Drug
Sandoz Files Suit Against FDA Over Exclusivity for Sanofi MS Drug
Novartis subsidiary Sandoz is suing the FDA over the new chemical entity (NCE) exclusivity it granted Sanofi’s multiple sclerosis drug Aubagio (teriflunomide), alleging the five-year protection it gave was unlawful and wrongly kept Sandoz’s generic teriflunomide from being reviewed by the agency.