Drug Development

Indevus Pharmaceuticals' IND for Nebido accepted by U.S. FDA

Published in Medical Letter on the CDC and FDA, April 12th, 2006

Indevus Pharmaceuticals, Inc. (IDEV) announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for Nebido, its long-acting injectable testosterone preparation for the treatment of male hypogonadism.

"We are pleased that the FDA, upon review of the clinical and non-clinical data package from the work of our partner Schering AG, has agreed with the design of our proposed pharmacokinetic study. The primary endpoint will require assessment of the average serum testosterone levels (Cavg) at steady state, measured in hypogonadal men receiving Nebido via intramuscular injection every 12 weeks," stated Glenn...

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Source: Medical Letter on the CDC and FDA (2006-04-12)

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