CMC Review Update: Evenity Sequence Variants, Sunosi Split-Tablet Risks, Mayzent Particle Size
Executive Summary
Redacted drug approval packages highlight key issues in US FDA quality reviews of Amgen’s Evenity, Jazz’s Sunosi and Novartis’ Mayzent.
You may also be interested in...
Amgen's Evenity Clears US FDA With Preferred Indication, Black Box Warning
Osteoporosis treatment romosozumab-aqqg indicated for postmenopausal women at high risk for fracture; advisory committee appears to have help persuade FDA that a black box would be sufficient to manage cardiovascular risk rather than a narrower indication.
Keeping Track: Approvals For Mayzent, Mavenclad, Duaklir, Jatenzo And Cimzia
The latest drug development news and highlights from our US FDA Performance Tracker.
Keeping Track: Thumbs Up For Zulresso And Sunosi, Thumbs Down For Zynquista And IV Meloxicam
The latest drug development news and highlights from our US FDA Performance Tracker.