Indevus Submits Data To FDA With New Dosing Regimen For Hypogonadism Candidate
This article was originally published in The Pink Sheet Daily
Executive Summary
Change in dose, additional data should not impact June 27 PDUFA date for Nebido, company says.
You may also be interested in...
Third Time’s A Charm? Endo’s Injectable Testosterone Finally Ready For Advisory Cmte.
FDA says reports of oil embolism and anaphylactic reations with other testosterone injectables also will be part of the discussion during an April 18 meeting of the Reproductive Health Drugs and Drug Safety and Risk Management advisory committees to review Aveed (testosterone undecanoate).
FDA Safety Concerns About Indevus’ Nebido Could Add 24 Months To Approval Timeline
Study to assess safety of hypogonadism therapy's oil-based depot injection could take 18 months.
FDA Safety Concerns About Indevus’ Nebido Could Add 24 Months To Approval Timeline
Study to assess safety of hypogonadism therapy's oil-based depot injection could take 18 months.