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Manufacturing Quality Drug Review

CMC Review Update: Evenity Sequence Variants, Sunosi Split-Tablet Risks, Mayzent Particle Size

  • Analysis

Executive Summary

Redacted drug approval packages highlight key issues in US FDA quality reviews of Amgen’s Evenity, Jazz’s Sunosi and Novartis’ Mayzent.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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