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.
You may also be interested in...
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.
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
Cidara’s Rezafungin: Dosing Convenience Warrants Antifungal’s Limited Approval, US FDA Panel Says
Use should be targeted for patients with candidemia/invasive candidiasis who require longer-term therapy and for whom daily intravenous administration with currently approved echinocandins is problematic, Antimicrobial Drugs Advisory Committee says.