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Lawmakers in the House introduced a bipartisan bill that would prevent brand drugmakers from thwarting competition by using restricted distribution networks to deny generics and biosimilars makers access to product samples they need to obtain FDA marketing approval. Read More
Competition from generic drugs allowed European healthcare systems and patients to save more than $100 billion last year, a new report shows. Generics competition nearly doubled access to drugs across seven key therapy areas: angiotensin II antagonists, antiepileptics, antidepressants, antipsychotics, antiulcerants, cholesterol regulators and oral antidiabetics, according to an IMS Institute for Healthcare Informatics report released earlier this month. Read More
Democratic members of the House Energy & Commerce Committee are pressing the FDA to expand the black box warning on extended-release opioids to include immediate-release versions of the painkillers as well. Read More
Orexigen Therapeutics and Takeda filed a patent infringement suit in federal court aimed at blocking Actavis from marketing a generic version of their anti-obesity drug Contrave. Read More
Mylan is expanding its nationwide recall of injectable gemcitabine and methotrexate to the hospital and user level, recalling eight more lots of the drugs after foreign matter was seen during quality control tests. Read More
Israeli drugmaker Teva will pay $24 million to settle a pay-for-delay lawsuit over its generic version of AstraZeneca’s heartburn relief drug Nexium. Read More
Drugmakers under consent decrees with the FDA may be able to deduct some payments made as part of their settlement with the agency when they file their tax returns, according to an informal opinion by the Internal Revenue Service’s chief counsel. Read More
The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug. Read More
Shire’s blockbuster attention deficit hyperactivity disorder drug Intuniv is facing competition as four generic versions of the therapy hit the U.S. market. Read More