American Testosterone Clinic for Men

Reading Time: 2 minutesMALVERN, Pa., May 30, 2013 /PRNewswire/ --Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (ENDP) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for Endo's long-acting testosterone undecanoate injection, AVEED, for men diagnosed with hypogonadism. The complete response letter did not include requests for the company to perform additional clinical studies. The FDA outlined the steps necessary to support approval of the NDA and updated the requirement for a Risk Evaluation and Mitigation Strategy (REMS). Specifically, the FDA has requested that the REMS include … Read more »

Reading Time: < 1 minuteCOLUMBIA, Mo. (AP) -- A University of Missouri study has found that male testosterone levels during competition varies depending on relationships among the competitors - and may be related to the formation of alliances in war. The study, released Thursday, tracked men on the island of Dominica playing dominoes or cricket. It concluded that sporting events can bring camaraderie to a community and fuel rivalries, with testosterone levels rising or falling depending on who is involved. Anthropology professor Mark Flinn says testosterone levels increased during and after victories over strangers or rivals, but didn't change much when friends competed against … Read more »

Reading Time: 2 minutesRandy Dotinga HealthDay Reporter Posted: Friday, May 10, 2013, 2:44 PM FRIDAY, May 10 (HealthDay News) -- Testosterone supplements are touted as a cure for low libido, but men who take them may reduce their odds of fathering a child, new research suggests. Many men who sought infertility treatment at two U.S. clinics reported taking prescription testosterone supplements, according to a new study. And in most cases their sperm counts skyrocketed after they stopped taking the male hormone. The study, limited to a pair of clinics in Alabama and Kansas, looked at the years 2005 to 2011. The researchers don't … Read more »

Reading Time: < 1 minute(Reuters) - Reviewers for the U.S. Food and Drug Administration said safety data on Endo Health Solutions Inc's twice-rejected testosterone injection Aveed was "concerning" and showed that the therapy was associated with severe and immediate post-injection adverse events. No deaths were reported from the post-injection reactions, but resuscitations and hospitalizations were required in some cases, the reviewers said in documents posted on the FDA's website on Tuesday. (http://link.reuters.com/dem47t) "There are no known approaches to predict or prevent the occurrence of an Aveed-related severe post-injection reaction for any patient," the FDA reviewers said. "It is unclear whether a 'slowly administered' intramuscular … Read more »

Reading Time: 2 minutesBy Toni Clarke (Reuters) - An advisory panel to the U.S. Food and Drug Administration was sharply divided on Thursday over whether a drug made by Endo Health Solutions Inc can safely be prescribed for men with low testosterone. A panel of outside medical experts split 9-9, with some members saying the drug, Aveed, offers a valuable alternative to existing products, especially since it is already sold under the brand name Nebido outside the United States. Dr. William Cooper, professor of pediatrics and preventive medicine at Vanderbilt University School of Medicine, said he did not find anything in the data … Read more »