All articles tagged with #teva pharmaceuticals
Over half a million bottles of Teva's blood pressure drug prazosin hydrochloride have been recalled due to elevated levels of a carcinogenic impurity, with the FDA classifying the recall as a Class II risk, indicating potential temporary health effects.
Over 580,000 bottles of Teva Pharmaceuticals' prazosin hydrochloride capsules have been voluntarily recalled due to contamination with a cancer-causing chemical, nitrosamine impurities, posing potential health risks. The FDA classifies this as a Class II risk, indicating possible temporary or reversible health effects. Consumers are advised to check for recall notices and consult healthcare providers for alternatives.
Over 580,000 bottles of Teva Pharmaceuticals' prazosin hydrochloride capsules have been voluntarily recalled due to contamination with a nitrosamine impurity that poses a cancer risk, with the FDA classifying the risk as moderate and advising consumers to seek further guidance.
Teva Pharmaceuticals has agreed to pay $225 million in criminal fines over five years and divest its generic cholesterol drug as part of a settlement to resolve charges related to price fixing. The U.S. Department of Justice announced the agreement, which also includes Glenmark Pharmaceuticals paying $30 million to resolve similar charges. The cases involve the price fixing of pravastatin, a widely used prescription drug for reducing cholesterol. This is the latest in a series of cases related to price fixing in the pharmaceutical industry, with seven companies collectively agreeing to pay over $681 million in criminal penalties. The agreements are deferred prosecution agreements, meaning the companies will not face trial or criminal punishment if they comply with the terms. Teva has also committed to donating $50 million worth of affected generic drugs to humanitarian organizations.
Gilead Sciences and Teva Pharmaceuticals have been cleared of allegations that they engaged in an illegal deal to inflate prices for HIV medicines. The lawsuit, filed four years ago, accused Gilead of using controversial business tactics such as pay-to-delay settlements and hindering the development of safer versions of medicines. The complex litigation was split into two trials, with the first trial involving a deal between Gilead and Teva.
Teva Pharmaceuticals USA has issued a voluntary nationwide recall of specific lots of Fentanyl Buccal Tablets CII due to a labeling error that omitted safety updates in the Product Insert/Medication Guide. The recall was initiated exclusively for Mayne Pharma Inc. under Mayne’s label. The main safety concern is a potential for incomplete information needed by health care providers and patients regarding safe use of the product. The likelihood of harm occurrence is considered remote, and to date, Teva has not received any complaints related to the product labeling.
The Biden Administration has urged the US Supreme Court to hear a patent appeal over drug labels involving Teva Pharmaceuticals and GlaxoSmithKline that could have significant ramifications for the generic-drug industry. The case involves "skinny labels" that allow generic drugmakers to launch their products earlier while avoiding liability for infringing brand-name drugmakers' patents. The US Solicitor General said Teva's generic version of GSK's heart drug Coreg could not have violated GSK's patent rights because Teva omitted the infringing use of the drug from its labeling.
The Biden Administration has urged the US Supreme Court to hear a patent appeal over drug labels involving Teva Pharmaceuticals and GlaxoSmithKline that could have significant ramifications for the generic-drug industry. The case involves "skinny labels" that allow generic drugmakers to launch their products earlier while avoiding liability for infringing brand-name drugmakers' patents. The US Solicitor General said Teva's generic version of GSK's heart drug Coreg could not have violated GSK's patent rights because Teva omitted the infringing use of the drug from its labeling.