Company Announces Revised Operating Plan to Respond to NEBIDO Delay
LEXINGTON, Mass., June 30 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for NEBIDO(R) related to a New Drug Application (NDA) submitted to the FDA in August 2007. The letter, received on June 27, 2008, indicated that the application may be approved if the Company is able to adequately respond to certain clinical deficiencies related to the product. The letter generally confirmed the Company's previously-announced indications from the FDA based on telephone discussions.
The FDA has expressed a concern about a relatively small number of patients in European post-marketing use who have experienced respiratory symptoms immediately following the intramuscular injection of NEBIDO 1000 mg, 4 cc injection volume, (versus the 750 mg, 3 cc injection volume used in the United States). The Company believes and the FDA concurs that the reaction is likely the result of a small amount of the oily solution immediately entering the vascular system from the injection site, a known, rare complication of oil-based depot injections.
The phenomenon is characterized by short-term reactions involving an
urge to cough, coughing episodes or a shortness of breath. In rare cases
the reaction has been classified as serious or the patient experiences
other symptoms such as dizziness, flushing or fainting. In the Company's
U.S. clinical trials of NEBIDO 750 mg (3 cc injection volume), the proposed
dose in the U.S., there was a single, mild, non-serious case of oil-based
cough observed. In addition, the FDA believes that four cases in the
|SOURCE Indevus Pharmaceuticals, Inc.|
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