Teva, BioSante’s Testosterone Gel for Men Wins Approval From U.S. FDA

Posted by Dr. Michael White, Updated on January 11th, 2018
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By Molly Peterson - Tue Feb 14 21:55:48 GMT 2012

Teva Pharmaceutical Industries Ltd. (TEVA) and BioSante Pharmaceuticals Inc. (BPAX) won U.S. clearance to sell Bio-T-Gel, a testosterone replacement therapy for men.

The Food and Drug Administration approved the transdermal gel, the agency said today in an e-mail. Teva, of Petach Tikva, Israel, will market Bio-T-Gel for men with low testosterone. The condition, known as hypogonadism, can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic in Rochester, Minnesota.

BioSante, the original developer of Bio-T-Gel, estimates the market for male testosterone products is more than $1.2 billion in the U.S., where hypogonadism affects as many as 5 million men. BioSante, of Lincolnshire, Illinois, licensed the gel to Teva, the world’s largest generic-drug maker, and will receive milestone payments and royalties when the drug is commercialized.

Abbott Laboratories (ABT) won FDA approval in April for a testosterone product known as AndroGel and later sued Teva, alleging that Bio-T-Gel infringed the product’s patent. Abbott, of Abbott Park, Illinois, and Teva settled the litigation in December without disclosing the terms, BioSante said Jan. 31 in a statement.

BioSante’s other experimental testosterone product, LibiGel, is a topical treatment applied to the arm for female sexual dysfunction. The company fell 77 percent, the most in 12 years, on Dec. 15 after the drug failed to work better than a placebo in two trials. BioSante said Jan. 31 that it would decide within 90 days whether to continue studying LibiGel.

To contact the reporter on this story: Molly Peterson in Washington at

To contact the editor responsible for this story: Adriel Bettelheim at

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Teva, BioSante’s Testosterone Gel for Men Wins Approval From U.S. FDA

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