Abbott Gets FDA Clearance for New Testosterone Gel
From Associated Press (April 29, 2011)
WASHINGTON -- Abbott Laboratories said Friday that it received U.S. regulatory approval for a new, more potent formulation of its testosterone gel.
The gel is approved for men with hypogonadism or low testosterone, a condition associated with fatigue, depression and various sexual dysfunctions.
The new Androgel 1.62 percent formula delivers 40.5 milligrams of gel in two pumps of the canister. The older, Androgel 1 percent formulation included 50 milligrams in four pumps. The two formulations are not interchangeable and both require a prescription.
The Food and Drug Administration approved the new formula based on a study showing 78 percent of men using the gel had normal testosterone levels after one year of use.
Drug companies are increasingly targeting low testosterone as a new market opportunity. About 14 million American men are believed to have irregularly low testosterone levels, though only 1.3 million are being treated, according to one industry estimate. The exact science is not completely understood, but researchers believe low testosterone levels can lead to a loss of energy, lower libido and osteoporosis.
Analysts estimate the current U.S. market for testosterone therapies at $1.1 billion. The market size has increased 23 percent since 2005, according to IMS Health, a health data firm.
Androgel is one of the oldest testosterone replacement products on the market, first launching in 2000. Last year Elli Lilly & Co. Inc. and Endo Pharmaceuticals both received approval for similar products. Lilly's Axiron solution is applied under the arms while Endo's Fortesta is applied to the inner thighs. Other testosterone products, including Androgel, are applied to the chest.
The FDA has placed warnings on all testosterone gels about the risks if the formulas rub off on children. The warning reads: "signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products."
North Chicago-based Abbott Laboratories said it expects to launch Androgel 1.62 percent in the second quarter of 2011.
Posted: May 2011