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Alteon, Inc.
U.S. FDA maintains clinical hold on ED study of alagebrium
October 26th, 2005
Alteon, Inc., (ALT) announced that it has been notified by the U.S. Food & Drug Administration's (FDA) Reproductive and Urologic Drug Products Division that it is maintaining the clinical hold previously placed on the company's phase IIa study of alagebrium in diabetic patients with erectile dysfunction. In June, the company announced that it had submitted preclinical toxicity data on alagebrium to two divisions of the FDA's Center for Drug Evaluation and Research (CDER), specifically the Division of Cardio-Renal Drug Products and the Division of Reproductive and Urologic Drug Products. The preclinical toxicity data were submitted in support of the company's view that...
Source: Elder Law Weekly (2005-10-26)
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