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Home » Takeda Sues FDA Over 505(b)(2) Approval of Hikma’s Mitigare
Takeda Sues FDA Over 505(b)(2) Approval of Hikma’s Mitigare
Takeda has asked a federal court to rescind the FDA’s approval last month of Hikma Pharmaceutical’s gout treatment Mitigare, claiming that the agency improperly cleared the rival company’s drug application without referencing Takeda’s own gout therapy Colcrys or its safety warnings.