FDA alerts health care providers of recall of anemia drug Omontys
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The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.
FDA approves Pomalyst for advanced multiple myeloma
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The U.S. Food and Drug Administration has approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow.
FDA approves Gleevec for children with acute lymphoblastic leukemia
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The U.S. Food and Drug Administration has approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated.
FDA approves new seasonal influenza vaccine made using novel technology
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The U.S. Food and Drug Administration has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.
FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
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The U.S. Food and Drug Administration approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
FDA expands use of Xarelto to treat, reduce recurrence of blood clots
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The U.S. Food and Drug Administration expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.
FDA takes action against thousands of illegal Internet pharmacies
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The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.
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- European Medicines Agency website on suspected side effect reports now in all 23 EU official languages
- European Medicines Agency boosts EU transparency