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Aeterna Zentaris Inc. Message Board

  • dcaf7 dcaf7 Feb 4, 2013 5:18 PM Flag

    FDA approves generic version of cancer drug Doxil

    It may accelerate Phase 3 study of AEZS-108 in endometrial cancer since doxil could be used as an active comparator now.

    Mon Feb 4, 2013 1:59pm EST

    * FDA approves Sun Pharma Global FZE's generic Doxil

    * First generic version to be approved by FDA

    * Approval expected to relieve shortages

    By Toni Clarke

    Feb 4 (Reuters) - U.S. health regulators have approved a generic version of the cancer drug Doxil in a move that could ease a months-long shortage that has threatened the lives of thousands of patients.

    The U.S. Food and Drug Administration said on Monday it approved a version of Doxil, known generically as doxorubicin HCI liposome injection, that is made by Sun Pharma Global FZE, a subsidiary of India's Sun Pharmaceutical Industries Ltd . It will be available in 20 milligram and 50 milligram vials.

    Sun's product is the first generic version of Doxil, which was approved in 1995 and is used to treat ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. Doxil is made by Johnson & Johnson.

    Doxil fell into short supply after manufacturing problems at an outside contract manufacturer, Ben Venue Laboratories Inc, a unit of German drugmaker Boehringer Ingelheim, suspended operations in November 2011 due to quality control problems.

    Last February, the FDA allowed for the temporary importation of Lipodox, which is made by Sun and contains the same active ingredient as Doxil. The agency said it intends to continue allowing the importation of Lipodox until Sun has made enough generic Doxil to meet demand.

 
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