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

 
• By Bowman Cox

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

chemistry
sequence variants, tablet splitting and particle size addressed by US FDA in recent quality reviews

Redacted chemistry review documents in several recent drug approval packages show the US Food and Drug Administration’s thinking on a range of quality issues.

Amgen’s Evenity was the latest monoclonal antibody to encounter growing questions about sequence variants. Meanwhile, Jazz had to convince the FDA it would be safe to split its scored Sunosi...

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