Keeping Track: Pharming’s Joenja, Cidara’s Rezzayo And Incyte’s Zynyz Headline US FDA Approval Bonanza
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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The Quality Lowdown: CMC Challenges Include Pfizer Unit's Quest For Injectable Acetaminophen
Pfizer’s InnoPharma unit finally overcame US FDA’s concerns about injectable acetaminophen GMPs and leachables. Meanwhile, Azurity resolved zonisamide manufacturing issues, Amphastar overcame doubts about naloxone’s nasal spray device, Incyte reused Zynyz CMC data, Cidara showed Rezzayo vials had enough powder, Pharming showed equivalence between Joenja tablets and capsules, and Orphalan avoided half-tablet stability testing of its functionally scored Cuvrior tablets.
New EU Filings Include Serplulimab For Lung Cancer & Zynyz For MCC
EU marketing applications for eight new products have begun the regulatory review process at the European Medicines Agency.
Cidara’s Novel Antifungal Approved For Antimicrobial-Resistant C. Auris Infections
Cidara’s US commercial partner Melinta will launch the novel echinocandin this summer, announcing pricing shortly before rollout. Limited indication follows recommendation of FDA advisory panel.