Content about Hypogonadism

March 15, 2013
FDA approves new packet version of AbbVie testosterone gel

The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

CHICAGO — The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

AbbVie announced the approval of the new version of AndroGel (testosterone) 1.62%, available in a packet containing 40.5 mg of testosterone in 2.5 g of gel and a packet with 20.25 mg of testosterone in 1.25 g of gel. The drug is used to raise testosterone levels in men with low or no testosterone, known as hypogonadism, estimated to affect nearly 14 million men in the United States.

February 1, 2013
Study finds men on long-acting opioids have lower testosterone

Men taking long-acting medications for chronic pain are almost five times more likely to have low testosterone levels, according to a new study by Kaiser Permanente.

OAKLAND, Calif. — Men taking long-acting medications for chronic pain are almost five times more likely to have low testosterone levels, according to a new study by Kaiser Permanente.

The study, which the healthcare system called the first to show a significant difference in risk between short-acting and long-acting opioids, appeared in The Clinical Journal of Pain.

May 21, 2012
GSK, Auxilium to co-promote testosterone therapy

The U.S. subsidiary of British drug maker GlaxoSmithKline and U.S.-based Auxilium Pharmaceuticals will co-promote a testosterone-replacement drug, the two said Monday.

MALVERN, Pa. — The U.S. subsidiary of British drug maker GlaxoSmithKline and U.S.-based Auxilium Pharmaceuticals will co-promote a testosterone-replacement drug, the two said Monday.

GSK and Auxilium announced an agreement for the co-promotion of Testim 1% (testosterone gel), used in men with conditions related to deficiency or absence of the hormone.

October 21, 2011
FDA approves new formulation of Watson's Androderm

The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a new formulation of a testosterone therapy made by Watson Pharmaceuticals, the drug maker said Friday.

Watson announced the approval of its Androderm (testosterone) transdermal system in the 2-mg and 4-mg formulation. The company said the new smaller size and lower-dose patch would provide "highly effective" testosterone administration with a 20% reduction in the active ingredient from the original strength. Watson plans to launch the new patch next month.

June 29, 2011
Lilly: Axiron improves hypogonadism symptoms among men

A topical drug made by Eli Lilly restored testosterone to normal levels in men with abnormally low testosterone, according to results of a late-stage clinical trial.

INDIANAPOLIS — A topical drug made by Eli Lilly restored testosterone to normal levels in men with abnormally low testosterone, according to results of a late-stage clinical trial.

Lilly announced results of a phase-3 trial of Axiron (testosterone) topical solution, a treatment for the condition, also known as hypogonadism. Study results also showed that the drug improved symptoms associated with it.

Hypogonadism results from damage or disease of the testicles, hypothalamus or pituitary glands that inhibits production of testosterone.

May 2, 2011
FDA approves Abbott's AndroGel

The Food and Drug Administration has approved a treatment made by Abbott for low testosterone in men, the drug maker said Friday.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a treatment made by Abbott for low testosterone in men, the drug maker said Friday.

Abbott announced the approval of AndroGel (testosterone gel) in the 1.62% strength, a clear, odorless topical gel for men with hypogonadism. The company already markets AndroGel in the 1% strength.

The new gel contains 40.5 mg of testosterone in two pump presses, while AndroGel 1% contains 50 mg in four pump presses, but the company said the two were not interchangeable.

March 3, 2011
Endo launches Fortesta

Endo Pharmaceuticals has launched a recently approved testosterone gel for men.

CHADDS FORD, Pa. — Endo Pharmaceuticals has launched a recently approved testosterone gel for men.

Endo announced Thursday the launch of Fortesta, approved by the Food and Drug Administration for treating low testosterone — or low T — in men, which affects about 14 million men in the United States; around 1.3 million of those men currently are receiving treatment, according to Endo.

November 24, 2010
FDA approves Axiron

Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.

INDIANAPOLIS — Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.

The FDA approved Axiron (testosterone) topical solution as a treatment for men with various conditions that lead to deficiency of the hormone. The drug, a controlled substance, is designed for application under the arm.

June 30, 2010
Endo resubmits application for approval for Fortesta

Endo Pharmaceuticals has resubmitted its application to the Food and Drug Administration for a testosterone...

March 17, 2010
Lilly acquires rights for hypogonadism treatment Axiron

Eli Lilly & Co. has acquired rights to a testosterone treatment from an Australian manufacturer,...