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Endo Pharmaceuticals 27 articles

Lawsuits alleging faulty birth control packaging remanded to federal court

A group of 113 women suing Endo Pharmaceuticals and other drug manufacturers over alleged defective packaging of its birth control pills were told by a Third Circuit panel that their product liability lawsuit belongs in federal court. The lawsuit was initially filed in November 2015 in the Philadelphia Court of Common Pleas by plaintiffs who claimed that certain brands of Qualitest birth control pills were packaged in error, putting users at risk of unintended pregnancy. The Philadelphia federal judge remanded the case back to state court, but the pills’ makers appealed on the grounds that the complaint was suitable for ... Read More

FDA panel says Opana ER too dangerous to stay on the market

A Food and Drug Administration (FDA) advisory panel charged with reviewing safety concerns with the powerful opioid Opana ER, determined that the risks outweighed the benefits, a decision that could lead to a market withdrawal. Opana ER is made by Endo Pharmaceuticals and is an extended release version of the painkiller oxymorphone. The company was granted approval from the FDA in 2006 to market an immediate-release oxymorphone called Opana IR. The patent expired in 2011, and Endo responded with an extended-release (ER) version that had been formulated with an “abuse deterrent” coating. The FDA told opioid manufacturers that it will ... Read More

US has substantial lead in global sales of testosterone replacement therapies

North America accounts for 85 percent of global testosterone replacement therapy sales in 2015, compared to other key geographic segments such as Europe, Asia Pacific, Middle East and Africa (MEA) and Latin America, according to a study conducted by global market intelligence company Transparency Market Research (TMR). The demand for the testosterone supplements was especially strong in the U.S., which accounted for 95 percent of North American testosterone treatment sales. Key players in global testosterone replacement therapy market are AbbVie, Inc.; Allergan plc.; Bayer AG; Endo Pharmaceuticals, Inc.; Eli Lilly and Company; Kyowa Kirin International plc.; Mylan N.V.; Novartis AG; ... Read More

Sales of testosterone gels, creams expected to slow over next eight years

Several top-performing testosterone replacement therapies will be losing their patents in the next few years, opening the door for less expensive generics and cutting into brand-name drug profits, according to a study conducted by Transparency Market Research. The study divided testosterone treatments into specific types – topical creams and gels, transdermal patches, injections, gum/buccal adhesives, implants, and oral drug forms. Creams and gels led the global market, particularly brands such as AndroGel by AbbVie, Axiron from Eli Lilly and Company, and Testim by Endo Pharmaceuticals. The creams and gels soared in sales in part because consumers found them easier to ... Read More

Endo pulls application on abuse-deterrent version of opioid Opana ER

The Food and Drug Administration’s commitment to cracking down on the prescription drug epidemic in the U.S. may seem too slight for those fighting for tighter restrictions on powerful opioid painkillers, but at least one drug company is feeling the heat. This week, Endo Pharmaceuticals, has chosen not to pursue a supplemental New Drug Application (sNDA) for its painkiller Opana ER. The application was for an abuse-deterrent version of the powerful opioid, a formulation the FDA is pushing drug manufactures to develop for future opioids. However, Endo chose to put its plans for the abuse-deterrent version of Opana ER on hold amid ... Read More

Testosterone side effects likely to hamper sales

The risk of cardiovascular events has hampered sales of testosterone replacement therapies, and numerous studies providing evidence of adverse events associated with the synthetic hormones are causing many people to look at the products in a negative light. These are just some barriers manufacturers of testosterone treatments face in the near future, an analyst with Transparency Market Research (TMR) predicts. Sales of testosterone replacement therapies have boomed in recent years with new formulations and brands entering the market, each pushing products through heavy direct-to-consumer marketing campaigns. The companies have even coined the phrase “Low T,” and suggested to men that ... Read More

Drug makers sued over testosterone side effects support mass tort status

A group of testosterone treatment manufacturers are supporting a motion filed by plaintiffs suing the drug makers over testosterone side effects to create a new mass tort program in Pennsylvania state court. The motion would consolidate about 30 pending cases in order to ease discovery and allow for better coordination with attorneys handling a related multidistrict litigation (MDL) in Illinois federal court. Both the plaintiffs and defendants agreed that the consolidation made sense from a practical perspective. The motion was filed in Philadelphia County Court of Common Pleas. Defendants include AbbVie Inc., Endo Pharmaceuticals, Inc., and GlaxoSmithKline LLC. The lawsuits ... Read More

Testosterone replacement therapy expected to grow rapidly around world

The testosterone replacement therapy (TRT) market is expected to grow rapidly around the world despite serious cardiovascluar risks associated with the hormone treatment, according to Transparency Market Research, a firm that provides current market trends and forecasts. Testosterone treatments are designed to boost levels of the hormone testosterone in men who have low testosterone due to injury or disease, a condition known as hypogonadism. It is not intended for men with naturally occurring age-related hypogonadism. The treatment has “gained momentum in the last decade,” according to the market research firm, primarly in the United States thanks to aggressive direct-to-consumer advertising by ... Read More

Women sue birth control pill maker for unplanned pregnancies

More than 100 women have joined a class action lawsuit in Pennsylvania State Court against the makers of a birth control pill claiming a packaging error resulted in unplanned pregnancies. The lawsuits allege Qualitest Pharmaceuticals, a subsidiary of Endo Pharmaceuticals, and its manufacturers, distributed packages of oral contraceptives with rows of pills in the incorrect order within the blister packs, which instructed women to take the placebo pills during a week that they should have been taking hormone pills. This, the lawsuit alleges, put them at risk of becoming pregnant. The lawsuits claim the defective packaging resulted in 113 accidental ... Read More

FDA approves long-acting testosterone with black box warning

A new long-acting testosterone therapy has been approved by the Food and Drug Administration (FDA), but the approval comes with a black box warning and strong prescribing restrictions. Aveed, made by Endo Pharmaceuticals, is a long-acting depot formulation of testosterone in caster oil and benzyl benzoate. It is administered in a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at four weeks after initiation of treatment, and then every 10 weeks thereafter. Aveed is approved to treat hypogonadism, a condition in which men produce too little of the hormone due to disease or defect. The FDA required ... Read More