FDA to review Teva testosterone gel

Wed, 04/13/2011 - 6:17am
The Associated Press

BioSante Pharmaceuticals Inc. said Wednesday the Food and Drug Administration will review an application for a testosterone gel it developed and then licensed to a unit of Teva Pharmaceutical Industries Ltd.

Regulators will complete their review of the gel, which aims to treat low testosterone levels in men, in November.

BioSante, based in Lincolnshire, Ill., developed the Bio-T-Gel and licensed it to Israeli-based Teva for late-stage clinical testing. Teva also is responsible for regulatory and marketing work on the gel, and BioSante will receive milestone and royalty payments once the product makes it to market.

Low testosterone can lead to hypogonadism, with symptoms that include fatigue, decreased energy and a lower sex drive. BioSante said the U.S. market for male testosterone products is more than $1.2 billion.


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