FDA takes action to protect consumers from dangerous medicines sold by illegal online 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 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.
FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers
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The U.S. Food and Drug Administration announced that the U.S. is now a "listed" countrydisclaimer icon with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.
FDA budget requests $4.7 billion
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The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA's ability to oversee imported food.
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.
More Pharma News ...
- FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
- FDA expands use of Xarelto to treat, reduce recurrence of blood clots
- FDA takes action against thousands of illegal Internet pharmacies
- FDA approves new treatment for advanced colorectal cancer
- New FDA task force will support innovation in antibacterial drug development
- FDA approves Lucentis to treat diabetic macular edema
- FDA approves first generic versions of Singulair to treat asthma, allergies