Article

Development Analysis and Strategic Insights from a 505(b)(2) Reformulation Product: Enzalutamide

2026-05-02

Abstract excerpt

<title>Abstract</title> <p> Background A growing number of reformulation products approved via the 505(b)(2) pathway highlights its value as an efficient mechanism for innovation built on well-characterized clinical assets. Objective To extract practical development lessons from the 505(b)(2) reformulation of enzalutamide (XTANDI®) by analyzing formulation strategy, scientific clinical bridging approaches, and...

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Literature Corpus work: 565fce37-ca7d-501a-bd7a-87f40f0cc403
DOI: 10.21203/rs.3.rs-9412915/v1

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