Doxil Shortage Solution: FDA Chooses Middle Ground, Allows Import Of Unapproved Version
FDA is allowing Sun Pharma Global FZE to import its unapproved liposomal version of doxorubicin, Lipodox, to alleviate a shortage, but has not yet given the drug full approval.
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Two years ago, Sun Pharmaceuticals was a key part of FDA’s efforts in helping drug shortages; now FDA has banned imports from one of its plants.
India’s Sun Pharmaceuticals says it is set to keep sales volumes growing in part through an aggressive acquisition strategy and a more diversified mix of products after third quarter profit more than quadruples.
Fresenius Kabi USA’s Norway plant is to supply the US with three injectable drugs used in total parenteral nutrition, primarily for treatment of premature infants; FDA has previously permitted importation of 11 other drugs that have been subject to shortages.