FDA approves first Boniva generics to treat or prevent osteoporosis
The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.
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FDA announces safety changes in labeling for some cholesterol-lowering drugs
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration.
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FDA acts to bolster supply of critically needed cancer drugs
The U.S. Food and Drug Administration announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama's Executive Order to help prevent future drug shortages.
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European Medicines Agency and United States Food and Drug Administration to share manufacturing site inspections
The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate.
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FDA approves first generic version of cholesterol-lowering drug Lipitor
The U.S. Food and Drug Administration approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets). Ranbaxy Laboratories Ltd. has gained approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths.
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Drug not Shown to be Safe and Effective in Breast Cancer Patients
FDA Commissioner Margaret A. Hamburg, M.D., said she is revoking the agency's approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.
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European Medicines Agency starts new review of cardiovascular risks of non-selective NSAIDs
The European Medicines Agency is reviewing the latest available data on the cardiovascular safety of non-selective NSAIDs (non-steroidal anti-inflammatory drugs).
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