Indevus Pharmaceuticals, Inc. today announced that based on a recent discussion with the U.S. Food and Drug Administration (FDA) regarding the NDA filing for Nebido(R), the Company expects the FDA to formally request that the Company provide additional safety data prior to approving Nebido. The Company currently believes that an additional study will be required in order to supply the necessary data. The Company expects to re-file for approval of NEBIDO in approximately 18 months followed by a 6 month FDA review. The Company will finalize the requirements and initiate the study following the receipt of formal communication from the FDA which the Company expects to receive by the original June 27, 2008 PDUFA date.
About NEBIDO
NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate under development for the treatment of male hypogonadism. NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.
The details can be read here.
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