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Hypogonadism - Male News

Related terms: Low Testosterone, Low T, Hypogonadotropic Hypogonadism - Male, Primary Hypogonadism - Male

FDA Approves Xyosted (testosterone enanthate) Injection for Testosterone Replacement Therapy in Adult Males

Posted 1 Oct 2018 by

EWING, N.J., Oct. 01, 2018 (GLOBE NEWSWIRE) – Antares Pharma, Inc. (NASDAQ:ATRS) today announced the approval of Xyosted (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). Xyosted is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot® auto injector. ...

TV Ads Help Drive Testosterone Supplement Sales

Posted 21 Mar 2017 by

TUESDAY, March 21, 2017 – TV ads have helped spur a boom in testosterone treatments, convincing many men that they need hormone replacement therapy, a new study suggests. In places where testosterone therapy ads ran, researchers discovered increases in testing for low T, initiation of testosterone replacement in new patients, and testosterone treatment without proper testing to see if hormone ...

Don't Ban Anonymous Sperm Donations: Study

Posted 31 Dec 2016 by

FRIDAY, Dec. 30, 2016 – Prohibiting anonymous sperm donations might lead to fewer donors and prompt those still willing to donate to ask for higher fees for donations, researchers report. While sperm donor anonymity is the norm in the United States, a number of other countries have banned anonymous donations. Most of those countries require all sperm donors to put identifying information into a ...

Men Don't Know About Risks to Fertility, Survey Finds

Posted 29 Dec 2016 by

WEDNESDAY, Dec. 28, 2016 – Many men don't know about risk factors that can lead to infertility, a new study reveals. In a survey, Canadian men could identify only about half of the activities and medical conditions that can harm their sperm count and reduce fertility. The men were more likely to know about risk factors such as cancer, smoking and steroid use. However, they were less aware of the ...

FDA Medwatch Alert: Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

Posted 25 Oct 2016 by

ISSUE: FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS.  The Anabolic Steroids Control Act of 1990 placed AAS, including ...

FDA Panel: Limit Testosterone Drug Use

Posted 18 Sep 2014 by

THURSDAY, Sept. 18, 2014 – There is little evidence that testosterone replacement therapy effectively treats normally sagging levels of the hormone in aging American males, a U.S. Food and Drug Administration advisory panel said Wednesday. The panel, from two key FDA committees, overwhelmingly voted, 20-1, to tighten use of the popular drugs and require drug makers to conduct tests assessing the ...

FDA to Probe Testosterone Therapy Claims, Safety

Posted 16 Sep 2014 by

TUESDAY, Sept. 16, 2014 – The U.S. Food and Drug Administration is focusing on the "Low T" fad, questioning whether the boom in testosterone replacement therapy is helping or harming the health of aging American males. At a joint meeting scheduled for Sept. 17-18, two key FDA committees will discuss whether doctors are prescribing testosterone therapy for too many men, and if misuse of the male ...

Common Chemicals May Lower Testosterone Levels, Study Finds

Posted 14 Aug 2014 by

THURSDAY, Aug. 14, 2014 – Exposure to certain chemicals commonly found in plastics and other products is associated with lower levels of testosterone in men, women and children, a new study says. Testosterone is the main sex hormone in men, but it is also involved in a variety of functions in both men and women, including brain function, bone density, physical growth, strength and heart health. ...

FDA Medwatch Alert: Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots

Posted 24 Jun 2014 by

[Posted 06/20/2014] ISSUE:  FDA notified health professionals and their medical care organizations that it is requiring the manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). BACKGROUND: The risk of ...

Upsher-Smith Receives Final NDA Approval For Vogelxo (testosterone) Gel

Posted 9 Jun 2014 by

Maple Grove, MN – June 4, 2014 – Upsher-Smith Laboratories, Inc., today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Vogelxo™ (testosterone) gel for topical use CIII. The company is preparing to launch Vogelxo™ in the near future. About Upsher-Smith Upsher-Smith Laboratories, Inc., founded in 1919, is a growin ...

FDA Approves Natesto (testosterone) Nasal Gel to Treat Men with Low Testosterone

Posted 6 Jun 2014 by

TORONTO (May 28, 2014) – Trimel Pharmaceuticals Corporation (TSX: TRL) announced today that the United States Food and Drug Administration (FDA) has approved Natesto (testosterone), formerly CompleoTRT™, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered vi ...

'Low T' Diagnosis Needs More Than a Blood Test, Experts Say

Posted 10 Mar 2014 by

MONDAY, March 10, 2014 – A blood test alone is not enough to diagnose low testosterone levels in men, and it should be used in tandem with a physical exam, a panel of experts says. The number of men in the United States diagnosed with low testosterone has increased significantly over the last decade, they noted. However, inconsistent laboratory practices and other problems result in unreliable ...

FDA Approves Aveed (testosterone undecanoate) Injectable Testosterone Replacement Therapy

Posted 6 Mar 2014 by

DUBLIN, March 6, 2014 /PRNewswire/ – Endo International plc announced today that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration (FDA) approval of Aveed (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. Aveed is ...

More Specialists Question Safety of Testosterone Therapy for Older Men

Posted 17 Feb 2014 by

MONDAY, Feb. 17, 2014 – Following the recent announcement from the U.S. Food and Drug Administration about the potential hazards of using testosterone supplements in older men, another group of experts is raising concerns about the popular treatments. In a statement, specialists in hormonal therapy at the Endocrine Society said the risks and benefits of testosterone supplements for older men ...

FDA Medwatch Alert: Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events

Posted 4 Feb 2014 by

[Posted 01/31/2014] ISSUE: FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is ...

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