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Testosterone News
Testosterone Tied to Incidence, Progression of Metabolic Syndrome
THURSDAY, July 11, 2024 – Testosterone is associated with a greater risk for development and progression of metabolic syndrome, particularly in transmasculine individuals, according to a study...
Male Birth Control Gel Shows Promise in Trial
MONDAY, June 3, 2024 – A new hormonal gel could one day be a potential form of birth control for men, researchers reported Sunday. “The development of a safe, highly effective and reliably r...
All-Cause Mortality Risk Up for Men With Low Testosterone
MONDAY, May 13, 2024 – The risk for all-cause mortality is increased for men with low testosterone, high luteinizing hormone, or very low estradiol, according to a review published online May 14 in...
FDA Approves Kyzatrex (testosterone undecanoate) for the Treatment of Male Hypogonadism
RALEIGH, N.C., Aug. 02, 2022 (GLOBE NEWSWIRE) – Marius Pharmaceuticals, a patient-centric healthcare company, today announced the approval of Kyzatrex (testosterone undecanoate) by the U.S. Food and...
FDA Medwatch Alert: FDA Alerts Customers to Voluntary Recall of Compounded Drugs Due to Sterility Issues by Drug Depot, LLC, dba APS Pharmacy
April 26, 2022 --FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of...
FDA Approves Tlando (testosterone undecanoate) for Male Hypogonadism
EWING, N.J., March 29, 2022 (GLOBE NEWSWIRE) – Antares Pharma, Inc., (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration g...
FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism
March 27, 2019 – The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have...
FDA Approves Xyosted (testosterone enanthate) Injection for Testosterone Replacement Therapy in Adult Males
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 Medwatch Alert: Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence
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...
FDA Medwatch Alert: Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.] ...
FDA Medwatch Alert: Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots
[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 ...
Upsher-Smith Receives Final NDA Approval For Vogelxo (testosterone) Gel
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 (ND...
FDA Approves Natesto (testosterone) Nasal Gel to Treat Men with Low Testosterone
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 C...
FDA Approves Aveed (testosterone undecanoate) Injectable Testosterone Replacement Therapy
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...
FDA Medwatch Alert: Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events
[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...