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Doxil Shortage Solution: FDA Chooses Middle Ground, Allows Import Of Unapproved Version

 
• By Martin Berman-Gorvine

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.

FDA is choosing to exercise “enforcement discretion” on imports of an unapproved version of Janssen Biotech Inc.’s cancer drug Doxil, but is explicitly not relaxing bioequivalence standards.

Doxil is an anthracycline topoisomerase inhibitor indicated for ovarian cancer, AIDS-related Kaposi’s Sarcoma and multiple myeloma

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