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Testim 98 articles

Testim maker files patent infringement lawsuit

Auxilium Pharmaceuticals, the maker of Testim® 1%, has filed a lawsuit against Watson Laboratories Inc. and related companies for allegedly violating patents protecting its best-selling testosterone replacement gel. Auxilium and FCB I LLC, a subsidiary of Xstelos Holdings Inc., filed the lawsuit in U.S. District Court for the District of New Jersey on May 23, accusing Watson Laboratories, Watson Pharmaceuticals, Inc. and Watson Pharma Inc. of infringing on 10 Testim® patents listed in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations, better known in the industry as the FDA’s “Orange Book.” According to Auxilium, the ... Read More

Testosterone wars heat up as Testim maker allies with GlaxoSmithKline

Testim manufacturer Auxilium Pharmaceuticals Inc. of Malvern, Pennsylvania, has entered a partnership with GlaxoSmithKline to drive up sales of the testosterone drug, the companies announced this week. Testim is a topical gel containing one percent testosterone, prescribed as a hormone-replacement therapy for men with clinically low testosterone levels and the physical slow-down that generally accompanies “low T,” as the condition is sometimes called. Testim and other testosterone replacement therapies are also sought after by men who take the drug for recreational purposes. The effects of excessive testosterone in men are virtually the same as taking steroids, with increased muscle mass ... Read More

Testosterone therapy can relieve symptoms of andropause

An estimated 20 to 30 percent of all men suffer from andropause, the male equivalent to menopause in women. It affects men in their mid 40s and older and carries symptoms such as mood swings, low sex drive and forgetfulness. But it can also lead to more serious problems, including osteoporosis. Just as women have hormone replacement therapy as a menopause treatment option, men have options, too. Testosterone therapy is the standard treatment for men who have been diagnosed with low testosterone levels. Treatments include injections or patches. The most popular treatment is a testosterone gel, which is sold under ... Read More

Drugmakers credit Androgel and Testim for first-quarter profit surge

The market for testosterone replacement drugs is booming, with no signs of easing in the future, market analysts say. Abbott Laboratories, the maker of Androgel 1.62% and Androgel 1% and Auxilium Pharmaceuticals, which makes Testim 1%, are aggressively marketing their testosterone drugs to millions of men in the U.S. with low testosterone levels, and those efforts are paying off. Sales of testosterone replacement drugs hit $1.6 billion in 2011, up 133 percent in just four years. According to data compiled by Bloomberg analysts, 5.6 million prescriptions were written for testosterone replacement therapies last year and sales are expected to triple ... Read More

NJ doctor may lose license for inappropriate testosterone replacement and painkiller prescriptions

The New Jersey Attorney General’s Office has moved to suspend the medical license of a doctor who, investigators allege, indiscriminately prescribed potent testosterone replacement drugs such as Androgel in addition to powerful prescription pain medications, including OxyContin and Roxicodone when they weren’t appropriate and necessary for patients to take. According to Newark’s Star-Ledger, Dr. Roger Lallemand Jr. wrote thousands of such prescriptions for patients visiting the three offices he maintained in Old Bridge and Asbury Park, New Jersey. The doctor told one patient, an undercover investigator with the U.S. Drug Enforcement Administration, that he offered testosterone drugs to all of ... Read More

Generic Testim will carry same black box warning as brand name

Watson Laboratories Inc. has filed an application to market a generic version of Auxilium Pharmaceuticals’ testosterone gel, Testim. Last year, the testosterone-containing treatment generated revenues of $207.9 million for Auxillium. Testim is a prescription, topical gel that is applied to the shoulders and upper arms of men. It was approved by the Food and Drug Administration (FDA) in 2002 to treat low testosterone. In 2009, the FDA announced that it was ordering the manufacturers of Testim and another testosterone gel, AndroGel, to include a boxed warning on the Testim 1% and AndroGel 1% labels. The agency required this action after ... Read More

Testosterone drug use building to an epidemic of health problems, doctors fear

AndroGel, Testim and other topical testosterone gel products were designed to restore healthy levels of functioning in men suffering from diminished bone and muscle mass, depression, weakened libido and other symptoms associated with low testosterone levels, or “Low T”. But now doctors are worried the testosterone drugs – coveted by many men for their sexual enhancement properties — are quickly creating another hormone-replacement health crisis in the United States. Bloomberg reports that AndroGel manufacturer Abbott Laboratories and other drug companies making and marketing testosterone drugs are offering to help some 14 million American men whose testosterone levels may be lower ... Read More

FDA places black box warning on topical testosterone gels

The Food and Drug Administration (FDA) has placed a black box warning on two separate topical testosterone gels following reports of secondary exposure to children, which can cause serious symptoms in children such as enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior. The two drugs listed by the FDA include AndroGel 1 % for topical use and Testim 1 % topical gel. The FDA warnings advise users of the product keep children away from unwashed or unclothed application sites in men using the gel. Women should also heed the warnings as they, ... Read More