Category Archives: TESTOSTERONE GEL

Reading Time: 2 minutesAlthough we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis. What: Shares in Repros Therapeutics vaulted higher by 10% earlier today after announcing that the FDA had accepted its application for approval of its drug Androxal. So What : Amid rising scrutiny of testosterone products, the FDA had previously offered up guidance to Repros regarding information necessary for an Androxal filing. In December, Repros reported that it had addressed the agency's questions and that it would file … Read more »

Reading Time: 3 minutesBy Kurt R. Karst In a Complaint filed last Friday in the U.S. District Court for the District of Columbia, Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company (collectively Perrigo) (represented by Hyman, Phelps & McNamara, P.C.) allege that FDA has shirked a duty under the Federal Food, Drug, and Cosmetic Act (FDC Act) by failing to timely act to update the Orange Book to add a Therapeutic Equivalence (TE) rating for Perrigos Testosterone Gel, 1%, drug product approved under NDA No. 203098. FDA approved NDA No. 203098, submitted pursuant to FDC Act 505(b)(2), well over a year ago on January … Read more »

Reading Time: 2 minutesBy RTT News, November 24, 2014, 07:18:00 AM EDT (RTTNews.com) - Endo International plc. (ENDP, ENL.TO) announced the acquisition of rights to Natesto (testosterone nasal gel), the first and only testosterone nasal gel for replacement therapy in adult males diagnosed with hypogonadism, from Trimel BioPharma SRL, a wholly-owned subsidiary of Trimel Pharmaceuticals Corp. (TRL.TO). Natesto was approved by the U.S. Food and Drug Administration in May of 2014. As per the terms of the agreement Trimel will receive an upfront payment of $25 million and could receive additional payments upon the achievement of certain regulatory and sales milestones. Additionally, Trimel … Read more »

Reading Time: < 1 minuteIn answer to that question, for the most part, yes, but as always it depends on the quality of the product you get. In order for a testosterone gel to work the quality of the product must be of high level. This is because in order for the substance to pass through the cell membranes of the skin its molecules must be able to fit between the gaps. For a testosterone gel to work not only does the quality have to be of high level but the formula also has to be formulated right. Several products contain very few ingredients … Read more »

Reading Time: < 1 minuteThe drug, which is called Tefina, is a 'use-as-required' testosterone nasal gel It has been designed for use by women who struggle to reach orgasm Tests showed it's safe and effective for use and doesn't cause side effects The developers say they will now work towards bringing it to the market By Emma Innes A new female orgasm drug could soon be available after successful trials. Tefina, a use-as-required nasal gel, was found to be safe and effective, its developers say. The product contains the sex hormone testosterone, low levels of which have been linked with poor libido. A new … Read more »

Reading Time: 2 minutesA pill to treat low sexual desire in women was rejected by U.S. regulators, a decision that has been appealed by the drugs maker in a bid to make it the first product for the disorder. The U.S. Food and Drug Administration based its decision to turn down the medicine on what the agency called a modest effect, closely held Sprout Pharmaceuticals Inc. said today in a statement. Sprout, based in Raleigh, North Carolina, is seeking approval of the therapy, known as flibanserin, as an option for women whose low libido causes stress in their lives. In clinical trials, Sprouts … Read more »

Reading Time: 2 minutesDosage and Administration for AndroGel 1% differs from AndroGel 1.62%. For dosage and administration of AndroGel 1.62% refer to its full prescribing information. The recommended starting dose of AndroGel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet), applied topically once daily in the morning to the shoulders and upper arms and/or abdomen area (preferably at the same time every day). To ensure proper dosing, serum testosterone concentrations should be measured at intervals. If the serum testosterone concentration is below the normal range, the daily AndroGel 1% dose may be increased … Read more »

Reading Time: < 1 minuteLow testosterone in men caused by various conditions is most often treated with testosterone gel (t gel). This prescription medication is a type of hormone replacement therapy and works by increasing testosterone in the body to a normal level. History has shown that hormone replacement therapy with t gel can be dangerous. That fact became evident for females in 2002 when a landmark study shook up the conventional wisdom about the benefits of estrogen replacement therapy for menopause, the period when women stop producing eggs and estrogen. The federal study showed that women taking hormone pills were more likely to … Read more »

Reading Time: < 1 minuteHomeDrug InformationFDA Approved Drugs2000 Medical Areas: Endocrinology View By:YearCompanyConditionsTherapeutic AreasDrug Names The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations. Company: Unimed Pharmaceuticals Approval Status: Approved February 2000 Treatment Area: For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone AndroGel is a hydroalcoholic gel to be applied to the clean, dry skin of the shoulders, upper arms and/or abdomen. The gel is absorbed through the skin and delivers testosterone to the patient for approximately 24 hours. This product is indicated for men with primary hypogonadism … Read more »

Reading Time: < 1 minuteMedication Guide ANDROGEL (AN DROW JEL) CIII (testosterone gel) 1% Read this Medication Guide that comes with ANDROGEL 1% before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about ANDROGEL 1%? Signs and symptoms of early puberty in a child may include: Stop using ANDROGEL 1% and call your healthcare provider right away if you see any signs and symptoms in a … Read more »

Reading Time: < 1 minuteMike Parker Mike Parker is a full-time writer, publisher and independent businessman. His background includes a career as an investments broker with such NYSE member firms as Edward Jones & Company, AG Edwards & Sons and Dean Witter. He helped launch DiscoverCard as one of the company's first merchant sales reps. Gynecomastia is a relatively common condition that causes abnormal breast enlargement in males. It has been estimated that up to 30 percent of young men will experience this condition. The condition frequently presents during puberty and typically disappears on its own within a few months. Cases where real breast … Read more »

Reading Time: 3 minutesAndroGel can transfer from your body to others. This can happen if other people come into contact with the area where AndroGel was applied. Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using topical testosterone products like AndroGel. Women and children should avoid contact with the unwashed or unclothed area where AndroGel has been applied. If a woman or child makes contact with the AndroGel application area, the contact area on the woman or child should be washed well with soap and water right away. … Read more »

Reading Time: < 1 minuteTestosterone cypionate is a type of anabolic steroids used to increase muscle mass while decreasing fat mass. As testosterone cypionate is considered to have a perfect score with regard to its anabolic rating, it is used as a bench mark and comparison with most other anabolic steroids. Cypionate is taken usually via injection, but also could be administered using an oral pill, or with an adhesive skin patch. Testosterone Cypionate Injection, for intramuscular injection, contains Testosterone Cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. The chemical name for Testosterone Cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1- oxopropoxy)-, (17)-. … Read more »

Reading Time: < 1 minuteLow testosterone in men caused by various conditions is most often treated with testosterone gel (t gel). This prescription medication is a type of hormone replacement therapy and works by increasing testosterone in the body to a normal level. History has shown that hormone replacement therapy with t gel can be dangerous. That fact became evident for females in 2002 when a landmark study shook up the conventional wisdom about the benefits of estrogen replacement therapy for menopause, the period when women stop producing eggs and estrogen. The federal study showed that women taking hormone pills were more likely to … Read more »

Reading Time: 2 minutesThe manufacturer of a potential female Viagra is appealing the Food and Drug Administration's letter denying the drug's approval, saying the company has gone above and beyond what is necessary to prove its treatment works and is necessary for many women. Sprout Pharmaceuticals received a Complete Response Letter (CRL) from the FDA regarding its new drug application (NDA) for flibanserin in October. At that time, the company said FDA asked for more information before the agency approved the drug for the U.S. market. But, Sprout believes that it has provided enough research on flibanserin, which the manufacturer lauds as a … Read more »

Reading Time: < 1 minuteDee Davies Ms. Davies owns two websites, has published one ebook and has previous writing experience with psychological research teams. Ms. Davies has a psychology degree, 11 FEMA emergency response certificates and 1 terrorism response certificate from the National Fire Academy. Men suffering from low testosterone receive testosterone replacement therapy. With testosterone gel therapy, the medicated gel is absorbed into the bloodstream through the skin. It then helps the body maintain a normal testosterone level. Gynecomastia is a relatively common condition that causes abnormal breast enlargement in males. It has been estimated that up to 30 percent... Testosterone gel therapy … Read more »

Reading Time: 2 minutesPosted: Monday, January 14, 2013, 1:00 AM By Mike Cohen, president of the Institute for Safe Medication Practices (ISMP), a nonprofit in Horsham devoted to medication safety. This post originally appeared on the blog "Checkup," at http://www.philly.com/checkup Could it be "Low T? By now, youve probably heard this line or seen a multitude of TV or newspaper ads for testosterone gel products. Drug makers have been tapping into this billion dollar market aimed at men over 40, which is when men may start to feel the signs of aging and decreased desire for sexual relations. The gel is easy to … Read more »

Reading Time: 2 minutesandrogel(testosterone) gel [Unimed Pharmaceuticals, Inc. A Solvay Pharmaceuticals, Inc. Company] CIII Rx only 500122/500127 Rev Apr 2007 AndroGel (testosterone gel) 1% is a clear, colorless hydroalcoholic gel containing 1% testosterone. AndroGel provides continuous transdermal delivery of testosterone, the primary circulating endogenous androgen, for 24 hours following a single application to intact, clean, dry skin of the shoulders, upper arms and/or abdomen. A daily application of AndroGel 5g, 7.5g, or 10g contains 50mg, 75mg, or 100mg of testosterone, respectively, to be applied daily to the skin's surface. Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability … Read more »

Reading Time: < 1 minuteGeneric Name: testosterone (tes-TOS-ter-one) Brand Name: AndroGel Children who have been exposed to testosterone gel have developed symptoms such as enlarged genitals; increased pubic hair, erections, or sex drive; aggressive behavior; and increased bone age. Contact the child's doctor right away if any of these symptoms occur. Children should avoid contact with unwashed or unclothed application sites in men who use testosterone gel. Closely follow the recommended instructions for use of testosterone gel. Treating symptoms of low testosterone in adult men when the body does not make any testosterone or not enough testosterone (hypogonadism). It may also be used for … Read more »

Reading Time: 2 minutesNEW YORK (AP) -- BioSante Pharmaceuticals Inc. said Thursday it will merge with ANI Pharmaceuticals in an all-stock deal worth about $94 million. BioSante has spent years developing LibiGel, a testosterone gel intended to treat sexual dysfunction in women, but has not been able to gain approval because of study failures and safety concerns. ANI markets branded and generic drugs and provides contract drug manufacturing services, and it had about $16 million in revenue in 2011. The companies said the deal combines BioSante's cash and expected revenue from licensing deals with ANI's current revenue. BioSante valued the deal at $93 … Read more »