California Supreme Court – Name Manufacturers Responsible for Generic Drug Labeling
Under the Food, Drug, and Cosmetic Act, drug manufacturers must submit a new drug application before it is able to market a new brand name drug. Additionally, the United States Food and Drug Administration must approve of the drug before it may be marketed. In the new drug application, a sample of the drug’s label must be included. … [Read more...] about California Supreme Court – Name Manufacturers Responsible for Generic Drug Labeling
Tysabri Labeling Changes Sought by European Regulators
Tysabri Labeling Changes. The European Medicines Agency wants to raise awareness of a deadly brain infection associated with the drug Tysabri. It recommended Thursday that the product information for Tysabri (natalizumab) be updated to include more information about the risk of progressive multifocal leukoencephalopathy … [Read more...] about Tysabri Labeling Changes Sought by European Regulators
Antidepressant Makers Ordered To Cite Suicidal Risk In Labeling
Antidepressant Suicidal Risk In Labeling. The health ministry has ordered drugmakers to revise the labeling for their antidepressant drugs to include a warning on an increased risk of suicide, the first order of its kind in Japan, according to ministry officials. Twelve types of drugs will be subject to the measure, the officials … [Read more...] about Antidepressant Makers Ordered To Cite Suicidal Risk In Labeling
FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing
FDA Updates Labeling For Viagra, Cialis and Levitra Associated With Eye Problems. The Food and Drug Administration (FDA) has approved updated labeling for Cialis, Levitra and Viagra to reflect a small number of post-marketing reports of sudden vision loss, attributed to NAION (non arteritic ischemic optic neuropathy), a condition … [Read more...] about FDA Updates Labeling for Viagra, Cialis and Levitra for Rare Post-Marketing
Diet Pill Labeling Not Comprehensible
Diet Pill Labeling Not Comprehensible. A Centreville woman who suffered a hemorrhagic stroke after taking an herbal dietary supplement Stacker 2 filed a class action suit against manufacturer NVE Pharmaceuticals and Quik Trip convenience store in U.S District Court of Southern Illinois. Marguerite Johnson, represented by Trent B. … [Read more...] about Diet Pill Labeling Not Comprehensible
FDA Updates Zelnorm Labeling
FDA Announced The Addition Risk Information Of Zelnorm. The Food and Drug Administration (FDA) today announced the addition of new risk information to the health professional labeling for Zelnorm (tegaserod maleate). Zelnorm is a prescription medication for the short-term treatment of women with irritable bowel syndrome (IBS) whose … [Read more...] about FDA Updates Zelnorm Labeling
