Indevus Plans End-Of-Summer NDA For Nebido Following Positive Phase III Results
This article was originally published in The Pink Sheet Daily
Executive Summary
Specialty pharma will price the quarterly injectable hypogonadism therapy to compete with current topical treatments.
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Indevus Submits Data To FDA With New Dosing Regimen For Hypogonadism Candidate
Change in dose, additional data should not impact June 27 PDUFA date for Nebido, company says.
Indevus Submits Data To FDA With New Dosing Regimen For Hypogonadism Candidate
Change in dose, additional data should not impact June 27 PDUFA date for Nebido, company says.
Indevus Submits Nebido For Hypogonadism
The long-acting testosterone could offer once every 12 week dosing compared to current treatment every two to three weeks.