Tagged Articles

Eli Lilly and Co. 13 articles

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

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

First testosterone lawsuit ends in mistrial

The much-anticipated first bellwether trial against AbbVie Inc. over alleged adverse cardiovascular side effects with its testosterone replacement therapy AndroGel ended in a mistrial this week after the lead plaintiff’s attorney was hospitalized due to an illness, according to Law360. The trial involved the case of Jeffrey Konrad, a Tennessee man who claims in 2010 he was lured to try testosterone therapy after watching advertisements promoting testosterone treatment for the so-called condition, Low T. The ads assured him that AndroGel could improve Low-T symptoms such as low sex drive, weight gain and depressed mood. Konrad asked his doctor to prescribe ... Read More

Testosterone Replacement Therapy trial requires Doc to reveal payments

A Boston-area doctor notorious for pushing testosterone replacement therapy to his patients for the past three decades was ordered to turn over his tax records indicating how much money he was paid by manufacturers of testosterone drugs. The order was made by U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois regarding a multidistrict litigation (MDL) accusing testosterone replacement therapy manufacturers of promoting testosterone treatment for so-called Low T without revealing that use of the hormone can cause serious medical problems, including life threatening heart attacks, strokes and blood clots. AbbVie is in the hot seat for ... Read More

Federal judge says Lilly cannot stop sales of generic versions of Axiron

Eli Lilly and Co. and its partner Acrux cannot stop competitors from selling generic versions of its testosterone treatment Axiron, a federal judge in Indianapolis ruled. Melbourne, Australia-based Acrux developed Axiron. Lilly, based in Indianapolis, has the exclusive rights to market the drug. The hormone replacement therapy product generated $29.3 million in global sales for the second quarter of 2016. The two companies filed a lawsuit last summer against a group of generic drugmakers including Perrigo Co., Actavis Laboratories and Lupin Pharmaceuticals, for infringing on their patent. U.S. Judge Sarah Evans Barker concluded that a formulation patent originally granted for the ... Read More

Type 2 diabetes drug class shares risk/benefit profiles

Johnson & Johnson is arguing that its type 2 diabetes treatment Invokana should have the same life-saving capabilities as its rival drug Jardiance showed in a new, large clinical trial. Jardiance, made by Eli Lilly and Co., announced last month results from a three-year study that showed Jardiance cut death risk by 32 percent in patients with type 2 diabetes at risk of heart attack and stroke. The news sent prescriptions for the drug skyrocketing, nearly doubling for the quarter to $340 million. Johnson & Johnson, whose drug Invokana shares the same class as Jardiance, wants in on that action. ... Read More

Newly approved type 2 diabetes drug carries black box warning for thyroid cancer risk

The Food and Drug Administration (FDA) has approved Eli Lilly and Co.’s new Type 2 diabetes treatment Trulicity, but the approval comes with a black box warning about an increased risk of thyroid cancer. Trulicity is an injectable drug in a family of type 2 diabetes medications known as glucagon-like peptide-1, or GLP-1, receptors. These drugs are in class of medications known as incretin mimetics that help control blood sugar levels in patients who do not produce enough insulin. Trulicity can be used as a single treatment or in combination with other commonly prescribed diabetes drugs including metformin, Actos and ... Read More