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The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral.
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A California jury found that Johnson & Johnson subsidiary McNeil Inc. was not guilty of manufacturing a defective Tylenol product that a family claims led to a child’s death. Read More
Canadian regulators will have sweeping new powers to order drug recalls, require labeling changes and postmarket studies, and release confidential business information under a rewrite of the country’s drug safety law. Read More
A federal judge has finalized an agreement by Pfizer to pay $325 million to settle claims it marketed off-label uses of its epilepsy drug Neurontin. Read More
European drug safety officials last week recommended lower dosing levels on Amgen’s angina drug Procoralan to lessen risks of heart problems, including heart attacks and excessively low heart rates. Read More
A New York federal judge has tossed out a lawsuit alleging Eli Lilly misled the public over withdrawal symptoms linked to its antidepressant Cymbalta. Read More
The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral. Read More
The entire class of prescription and over-the-counter proton pump inhibitors do not require a boxed warning, but some prescription PPIs should contain a medication guide, the FDA said in response to a long-waiting citizen petition. Read More
The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More
India’s national drugs authority is again surveying pharmacists and testing drug samples in an effort to better grasp the extent of the country’s counterfeit and substandard drugs problem. Read More