Refusal Actions by FDA as Recorded in OASIS for Venezuela

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Lilly del Caribe, Inc. (PR01)
    Carolina, PR  00985                            NOL-DO  112-1453803-8/1/1
    66VCE99   929420366112 STRATERA CAPSULES
                        21-AUG-2008                        NO ENGLISH

    Mrw
    Caracas , VE                                   NOL-DO  112-1453803-8/1/2
    54FFL99   929420366112 ARNICA
                        21-AUG-2008                        LACKS FIRM
                                                           LABELING

    Inversiones Rodven
    Caracas , VE                                   NOL-DO  112-1622868-7/1/3
    53LC-99   860786271489 STRIDERM
                        22-AUG-2008                        CSTIC LBLG

    Inversiones Rodven
    Caracas , VE                                   NOL-DO  112-1622868-7/1/1
    53LC-99   body gel
                        22-AUG-2008                        CSTIC LBLG
                                                           COSMETLBLG