US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies
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Valacyclovir <strong>Regulatory</strong> Path• <strong>505</strong>(b)(2) NDA as a new molecular entity– Acyclovir is RLD• Can rely on some acyclovir nonclinical & clinical data– Nonclinical studies for NME– Full Phase 1 PK program– Phase 2 dose-ranging– 1 adequate <strong>and</strong> well-controlled Phase 3 study• 5 Years marketing exclusivity
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