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While compounded alternatives gained traction when there were supply constraints, the FDAs intervention highlights the regulatory and evidentiary advantages of approved therapies including FDA-reviewed labeling, established safety and efficacy data, and regulated manufacturing oversight

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The lesson for IP teams is not simply conduct pediatric studies. It is to audit every Orange Book-listed patent for pediatric exclusivity eligibility before prioritizing the IP calendar, because the extension value is directly proportional to the base revenue of the product in the 6-month window