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Part VI: Hatch-Waxman Mechanics and Paragraph IV Litigation The Orange Book and Its Strategic Function The FDAs Approved Drug Products with Therapeutic Equivalence Evaluations, universally called the Orange Book, lists all patents that the NDA holder certifies as covering the approved drug product or a method of using it

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Design Defects and Strict Liability Some legal actions argue that Wegovy has inherent design defects that make it unreasonably dangerous for consumers