Regulatory Actions

BioSante Pharmaceuticals Announces Initiation of LibiGel(R) (Transdermal Testosterone Gel) Phase III Safety Study

Published in Medical Letter on the CDC and FDA, January 20th, 2008

BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) announced that it has initiated its Phase III safety study of LibiGel. This study design is a result of an agreement with the U.S. Food and Drug Administration (FDA) on key FDA requirements for the development and approval of LibiGel in the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD).

The LibiGel Phase III safety study protocol was finalized after meetings and discussions with FDA representatives from the Division of Reproductive and Urologic Products, the Division of Cardio-Renal Products and the Office of Biometrics III (statistics). The primary focus of BioSante's...

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Source: Medical Letter on the CDC and FDA (2008-01-20)

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