Existing European Data Will Be Used for NDA Resubmission
Planned For First Quarter 2009
LEXINGTON, Mass., Sept. 26 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) with regard to the additional data and risk management strategy that will lead to re-submission (complete response) of the New Drug Application (NDA) for NEBIDO(R) in the first quarter of calendar 2009. The re-submission database will include experience from over 14,000 injections in more than 2,600 patients, all of which come from existing clinical trials conducted in the U.S. and post-marketing studies that have been conducted in Europe. FDA stated that the number of patients and the number of injections of testosterone undecanoate from these studies appear to provide an adequate size database to determine the precise incidence of serious post-injection, oil-based reactions.
Indevus and FDA also agreed on an education plan to minimize the risks associated with the clinical use of testosterone undecanoate intramuscular injection, namely, to reduce the incidence and/or severity of the serious oil- based reactions. Further, Indevus and FDA agreed to obtain skin-testing data to characterize an allergic component to the drug or any of its excipients in certain patients. Indevus has also agreed to conduct a large, simple post- marketing study of the safety of NEBIDO in approximately 10,000 patients.
"We are very pleased that we can provide to FDA additional data from
existing clinical trials to satisfy FDA's desire to understand the
incidence of these rare oil-based reactions, without the need to conduct
|SOURCE Indevus Pharmaceuticals, Inc.|
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