Indevus withdraws hypogonadism NDA to address safety concerns
This article was originally published in Pharmaceutical Approvals Monthly
Indevus will withdraw the NDA for Nebido, its testosterone formulation for male hypogonadism, and conduct an additional safety study as a result of recent discussions with FDA, the company announces June 4. Indevus will need about 18 months to study complications related to Nebido's (testosterone undecanoate) oil-based depot injection administration, and then plans to refile the NDA. Indevus expects FDA to request new data calculating the incidence of adverse events related to oily injection solution entering the patient's vascular system, and proposals to mitigate incidence with the current dosing regimen
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