FDA Accepts New Drug Application for Nebido

The FDA will review Indevus Pharmaceuticals’ new drug application for Nebido, a long-acting injectable testosterone preparation for male hypogonadism.

The application contains data from six clinical studies in which more than 400 patients received at least one dose of Nebido. At least 300 of these patients were treated for more than one year, Indevus said.

The application also includes postmarketing data from safety reporting through June.