American Testosterone Clinic for Men

Reading Time: < 1 minuteRecently, Perrigo Company (PRGO) announced that it has gained approval from the US Food and Drug Administration (FDA) pertaining to its New Drug Application (NDA) for testosterone gel 1%. We note that the New Drug Application filed by the company with the US regulatory body included a bioequivalence study comparing testosterone gel 1% with AbbVie Inc.'s (ABBV) AndroGel 1%. We note that AndroGel 1% (testosterone gel 1%) is marketed for treating males (above 18 years of age) with low or no testosterone in their body. The annual sales of this product were approximately $705 million, according to data released by … Read more »

Reading Time: 2 minutesALLEGAN, Mich., Feb. 5, 2013 /PRNewswire/ --Perrigo Company (Nasdaq: PRGO;TASE) announced that it has received U.S. Food and Drug Administration approval for its New Drug Application (NDA) for testosterone gel 1%.Perrigo's NDA included a bioequivalence study that compared its product to AbbVie's AndroGel 1%. (Logo: http://photos.prnewswire.com/prnh/20120301/DE62255LOGO ) AndroGel 1% (testosterone gel 1%) is indicated to treat adult males who have low or no testosterone. Annual sales were approximately $705 million annually, as measured by Symphony Health. Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and continued focus on bringing … Read more »

Reading Time: 2 minutesABBOTT PARK, Ill., Dec. 17, 2012 /PRNewswire/ --Testosterone is an important androgen hormone in the health and well-being of men and women. Testosterone levels are associated with sexual development, libido, protection against osteoporosis, and cardiovascular health. In men, insufficient testosterone levels (hypogonadism) have been linked to obesity and low libido. In women, polycystic ovary syndrome (PCOS) is a common endocrine disorder that can result in excessive production of testosterone, leading to infertility, irregular or absent menstrual periods, and hirsutism (excess body and facial hair). Inappropriate testosterone levels can also result in precocious or delayed puberty. The measurement of testosterone plays … Read more »

Reading Time: < 1 minuteSALT LAKE CITY--(BUSINESS WIRE)-- Lipocine Inc. (www.lipocine.com) announced today that the Company recently met with the FDA and received guidance and go-ahead for the Companys pivotal Phase III study for its oral testosterone replacement therapy (LPCN 1021). Lipocine presented the results of its Phase II trials to the FDA that indicated LPCN 1021 exceed both Primary and Secondary endpoints that are required according to FDA criteria for approval. As a result of the meeting, Lipocine is preparing plans to initiate its Phase III study. We are pleased with FDA feedback into the design of our Phase III protocol and look … Read more »