U.S. Food and Drug Administration
Ampio Submits Type B Pre IND Meeting Request to the FDA for Zertane
Published in Pharma Business Week, April 23rd, 2012
2012 APR 23 -- Ampio Pharmaceuticals, Inc. (NASDAQ:AMPE--News) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), announced that it submitted to the FDA a pre IND package on Zertane™, its on-demand premature ejaculation drug, for a meeting and discussion on the approval path under the 505(b) 2 regulation/registration requirement in the US.
Michael Macaluso, Ampio's CEO, noted that "Zertane™ successfully completed two phase II and two phase III studies in Europe that met all end points including efficacy and safety. A follow on 12 weeks open label study of...
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Source: Pharma Business Week (2012-04-23)
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