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

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