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Axiron 39 articles

Lilly pulls Axiron from Korean market

Eli Lilly & Co. has taken its topical testosterone replacement therapy Axiron off the market in Korea after gaining the blessing of the country’s Ministry of Food and Drug Safety. The company said that it made the decision to withdraw the treatment from the market in Korea due to several factors including “low male menopause awareness and the existence of substitutable medicines.” Axiron was developed by Australian pharmaceutical company Acrux and marketed by U.S.-based Lilly. It was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the treatment of hypogonadism, a condition in which men do not ... Read More

Eli Lilly announces settlement agreement of testosterone side effects cases

A month before facing its first bellwether trial in a multidistrict litigation involving testosterone side effects, Eli Lilly& Co., announced it had reached a global settlement in all cases filed against it. The drug company faced claims that the company failed to warn that its testosterone replacement therapy Axiron could cause potentially deadly heart attacks, strokes and blood clots. The pharmaceutical company told U.S. District Judge Matthew Kennelly that it had entered into a memorandum of understanding. As a result, Judge Kennelly canceled two upcoming trial dates – in January and March – involving Axiron. The trials involved the case ... Read More

Teva launches generic Axiron despite heart risks

Teva Pharmaceuticals Ltd., announced it has launched CII, a generic version of the testosterone replacement therapy Axiron, a topical solution of the prescription medication used to treat adult males with low levels of testosterone due to injury, disease or defect. “We are pleased with the result in the district court, which has helped Teva add yet another product to our industry-leading generic portfolio, providing savings to our customers and to patients,” said Andy Boyer, Teva’s President and CEO, Global Generic Medicines, North America. Axiron is manufactured by Eli Lilly and Co., and has annual sales of about $247 million in ... Read More

Lilly discontinues Axiron testosterone solutions

Eli Lilly & Co. is discontinuing two of its Axiron testosterone replacement therapy solutions and its authorized generic testosterone solution because there are multiple manufacturers that are currently selling the products, according to MPR. The discontinued products include Axiron 30mg /1.5mL with the NDC 0002-1975-90, Axiron 30mg/1.5mL with the NDC 0002-1975-61, and generic testosterone 30mg/1.5mL with the NDC 66993-963-89. Axiron solution is an androgen used to treat adult men with congenital or acquired primary hypogonadiasm or hypogonadotropic hypogonadism. It is supplied as a 90mL pump containing 60 metered pump or twist actuations with an applicator. Eli Lilly claims that the ... Read More

Axiron safety label updated

The Patient Counseling Information/Patient Information/Medication Guide for the topical testosterone gel Axiron has been updated to include clarifications such as ensuring patients know how to administer the correct dosage as well as understanding that they should not drink the product. Axiron is a testosterone supplement intended for men with low levels of the male hormone due to injury or disease. It is a topical gel that is applied to the armpits. Patients are advised to wash their hands right away with soap and water after applying the gel and, once the solution has dried, to cover the area with clothing to ... Read More

Axiron side effects trial dates set

Two cases among more than 6,000 lawsuits waged against Eli Lilly and Co. over testosterone side effects have been selected by the U.S. District Court for the Northern District of Illinois to serve as bellwether trials in the Testosterone Replacement Therapy Product Liability multidistrict litigation (MDL). U.S. District Judge Matthew K. Kennelly selected the case of Tracy Garner and the case of John Debroka Jr. to serve as bellwethers. Garner claims to have had a heart attack after initiating testosterone therapy with Lilly’s Axiron. Debroka alleges he developed deep vein thrombosis, a blood clot deep in the veins, after taking ... Read More

First two Axiron side effects trials scheduled

AbbVie isn’t the only testosterone treatment manufacturer facing heat in the multidistrict litigation (MDL) alleging the hormone treatment is linked to heart attacks, strokes, blood clots and deaths. This week, the Illinois federal judge overseeing the MDL selected the first two cases that will go to trial against Eli Lilly and Co., according to Law360. AbbVie faces the first bellwether trials in the MDL, with the latest ending in mistrial earlier this month after the lead plaintiff’s attorney fell ill. That case will be retried in September. AbbVie , maker of the top selling AndroGel, will strand trial in the ... Read More

Man blames heart attack on Low T therapy

Tracy Garner was intrigued by advertisements for testosterone replacement therapy to boost sex drive and improve muscle mass in men with “Low T.” He asked is doctor about the hormone therapy, and in March 2013, Garner was prescribed Eli Lilly and Co.’s Axiron. A few days later, he had a heart attack. Garner is one of about 6,000 men suing manufacturers of testosterone replacement therapy, alleging the drug companies engaged in aggressive marketing of a prescription drug for off-label use – the treatment of so-called Low T, according to Law360. Testosterone treatments are intended for men with hypogonadism, a condition ... Read More

FDA approves new warnings for testosterone gel Axiron

The Food and Drug Administration (FDA) has approved the updated safety label for the testosterone gel Axiron to include new warnings for abuse and dependence. The warning is being placed on all testosterone replacement therapies as well as anabolic androgenic steroids (AAS). “Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication in combination with other anabolic androgenic steroids,” the FDA warned in a Safety Announcement informing the public of the required new warnings. Axiron is intended for men with hypogonadism, a condition in which the body does not produce enough testosterone due to ... Read More

AbbVie asks judge to toss bellwether case in testosterone side effects MDL

Drug maker AbbVie Inc. asked a federal judge to toss a lawsuit alleging the company’s testosterone replacement therapy AndroGel causes injuries, arguing the plaintiff withheld information about his condition until after the discovery process was completed. AbbVie told U.S. District Judge Matthew Kennelly in Chicago that Froylan Garcia’s claim was no longer valid because his attorney did not find an expert witness to back up his claims that AndroGel caused him to develop a blood clot in 2013. Garcia’s case was one of eight selected by Judge Kennelly to serve as bellwether trials in a multidistrict litigation (MDL) of more than 5,500 ... Read More