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Thus, approval of a Section 505(b)(2) NDA can be stalled until all the listed patents claiming the referenced product have expired, until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired, and, in the case of a Paragraph IV certification and subsequent patent infringement suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case that is favorable to the Section 505(b)(2) applicant
Injectable Wegovy is also approved for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to severe liver fibrosis
Evaluating thyroid cancer risk in glucagon-like peptide-1 analog users with thyroid nodules
The medications, known as GLP-1 receptor agonists, mimic this hormone to regulate several key bodily functions
