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BioSante Pharmaceuticals Announces FDA Approval for Bio-T-Gel
Posted 15 Feb 2012 by Drugs.com
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb 15, 2012 - BioSante Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Bio-T-Gel, which is licensed by BioSante to Teva Pharmaceuticals USA, Inc. Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Male hypogonadism is generally characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis. Bio-T-Gel was initially developed by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive royalties and may receive certain milestone payments upon commercialization of Bio-T-Gel. The current U.S. market for male testosterone products is estimated at over $1.6 billion. “We are pleased that Bio-T-Gel will provide another t ... Read more
Related support groups: Testosterone, Hypogonadism -- Male
For Older Men, Lowered Testosterone May Mean Muscle Loss
Posted 28 Oct 2011 by Drugs.com
FRIDAY, Oct. 28 – Lowered testosterone levels are associated with the loss of lean muscle mass and lower body strength in older men, a new study finds. Loss of muscle mass and strength contributes to frailty and is associated with mobility problems, falls and bone fractures, the study's authors say, and men lose more muscle mass and strength than women as they age. That suggests that levels of sex hormones, particularly testosterone, could influence age-related changes in body composition and physical function, according to researchers led by Dr. Erin LeBlanc, of Kaiser Permanente Northwest in Portland, Ore. Their study included almost 1,200 men aged 65 who had their levels of sex steroids measured and were then followed for an average of 4.5 years. Their body composition was checked using high-tech scans, and their physical abilities were evaluated through exercises that assessed ... Read more
Related support groups: Hypogonadism -- Male
Age Alone May Not Cause Testosterone to Fall
Posted 7 Jun 2011 by Drugs.com
TUESDAY, June 7 – Testosterone levels don't necessarily drop with age, but it's more likely among older men with declining general health, a new study suggests. Bucking prior research indicating age-related testosterone deficiency contributes to deteriorating health, fatigue and libido loss, Australian researchers found that blood testosterone amounts didn't fall in older men with optimal health. The data, gathered as part of the Healthy Man Study, is scheduled to be presented Tuesday at the Endocrine Society's annual meeting in Boston. "Our interpretation is that age in and of itself does not reduce blood testosterone levels . . . but the accumulating disorders as men age, some preventable and some not, some genetic and some environmental, do have such an impact, albeit pretty modest," said study author Dr. David Handelsman, a professor of reproductive endocrinology and andrology at ... Read more
Related support groups: Testosterone, AndroGel, Testim, Hypogonadism -- Male, Axiron, Androderm, Testosterone Enanthate, Fortesta, Delatestryl, Depo-Testosterone, Testopel, AndroGel 1.25 g/actuation, Striant, Everone, Depotest
Endo Pharmaceuticals Receives FDA Approval for Fortesta (Testosterone) Gel as a Class III Product for Topical Use for Men With Low Testosterone
Posted 3 Jan 2011 by Drugs.com
CHADDS FORD, Pa., Dec. 29, 2010 /PRNewswire via COMTEX/ --Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Fortesta Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis. Low T is a condition that has an estimated prevalence in nearly 14 million men in the United States, yet only about 1.3 million, (9 percent) are currently being treated. Endo Pharmaceuticals expects to introduce Fortesta Gel in the United States in early 2011. "Declining blood levels of testosterone can occur in men beginning as early as age 40. The symptoms of low testosterone can be non-specific and often associated with other chronic medical ... Read more
Related support groups: Testosterone, Hypogonadism -- Male
Lilly and Acrux Receive FDA Approval for Axiron (Testosterone) Topical Solution CIII
Posted 24 Nov 2010 by Drugs.com
INDIANAPOLIS, Ind. and MELBOURNE, Australia, Nov. 23, 2010 /PRNewswire-FirstCall/ – Eli Lilly and Company and Acrux announced that the U.S. Food and Drug Administration (FDA) has approved Axiron (testosterone) topical solution CIII for replacement therapy in men for certain conditions associated with a deficiency or absence of testosterone. Safety and efficacy of Axiron in males younger than 18 years of age have not been established. Axiron is the first testosterone topical solution approved for application via an armpit (underarm) applicator. Other forms of testosterone replacement therapy include: oral tablets, buccal tablets, subcutaneous pellets, transdermal patches, injections and topical gels applied by the hands. Although the total number of men with testosterone deficiency is unknown, it has been estimated that up to 13 million men over 45 years of age in the U.S. may have ... Read more
Related support groups: Hypogonadism -- Male
Low Testosterone in Older Men Less Common Than Thought
Posted 16 Jun 2010 by Drugs.com
WEDNESDAY, June 16 – In describing a set of concrete symptoms for "male menopause" for the first time, British researchers have also determined that only about 2 percent of men aged 40 to 80 suffer from the condition, far less than previously thought. Male menopause, also called "andropause" or late-onset hypogonadism, supposedly results from declines in testosterone production that occur later in life, but there has been some debate on how real the phenomenon is, the study authors noted. "Some aging men indeed suffer from [male menopause]. It is a genuine syndrome, but much less common than previously assumed," concluded Dr. Ilpo Huhtaniemi, senior author of a study published online June 16 in the New England Journal of Medicine. "This is important because it demonstrates that genuine symptomatic androgen deficiencies [androgens are male hormones] is less common than believed, and ... Read more
Related support groups: Hypogonadism -- Male
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testosterone, AndroGel, Testim, Axiron, Androderm, Testosterone Enanthate, Pregnyl, Novarel, Chorionic Gonadotropin, view more... Fortesta, Gonal-f, Delatestryl, Depo-Testosterone, Methitest, methyltestosterone, Follistim, chorionic gonadotropin (hcg, Testopel, Android, Profasi, Androxy, Testred, Ovidrel, Depotest, Striant, Everone, Chorex, FIRST-Testosterone MC, follicle stimulating hormone, Gonic, FIRST-Testosterone, Halotestin, Gonal-f RFF, Testopel Pellets, fluoxymesterone, Bio-T-Gel, Follistim AQ Cartridge, Gonal-F Pen, Choron-10, Puregon, Chorigon, Andro-Cyp 200, Oreton Methyl, Testoderm, Testro AQ, Testolin, Android-25, Android-10, Profasi HP, Follistim AQ, Gonal-f RFF Pen, Virilon, Testamone-100, Virilon IM, Durathate 200, Histerone, Meditest, Testro, Duratest, Depandro 100, Delatest, Andro LA 200, Andro-Cyp 100, Testro-LA