New supplies of two currently hard-to-find cancer drugs are on the way, according to the FDA. As Dow Jones Newswires reports , the FDA said it would allow the temporary importation of Lipodox, made by Sun Pharma Global FZE and distributed by Caraco Pharmaceutical Laboratories, as a substitute for Johnson & Johnson’s Doxil. The drugs have the same active ingredient. Doxil has been in short supply since about mid-2011. New supplies of Lipodox are “expected to end the shortage and fully meet patient needs in the coming weeks,” the FDA says. The FDA also said it had approved a new manufacturer — APP Pharmaceuticals — of preservative-free methotrexate, a drug that is used to treat a type of children’s leukemia and has also been in short supply . The drug should be available in March, the agency says. Hospira has also “expedited release of additional supplies” of preservative-free methotrexate — 31,000 vials worth, enough to cover a month’s worth of demand, the FDA says. The agency “is actively working with other manufacturers … including Mylan and Sandoz Pharmaceuticals” to meet patient needs, it says. DJN notes that both shortages can be traced back to the closing of a Ben Venue Laboratories plant in Ohio. Ben Venue, a unit of Boehringer Ingelheim, shut down the plant to deal with manufacturing issues. Bonus: GAO Report Blames Drug Shortages on Manufacturing Problems Image: iStockphoto
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FDA Approves New Suppliers for Scarce Cancer Drugs