Refusal Actions by FDA as Recorded in OASIS for Switzerland

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


    ELKO ORG.LTD
    SAN VITTORE GR , CH                            ATL-DO  XXX-0152493-4/1/1
    64LDJ67   Clobetasol Propionate Cream 0.05% (Mekako Brand)
                        07-MAR-2008                        NO ENGLISH
                                                           UNAPPROVED

    Esro Ag
    Kilchberg , CH 8802                            FLA-DO  KL3-0084227-7/1/1
    76M--CF   BRUSH
                        10-MAR-2008                        REGISTERED

    Roche Pharma
    Reinach , CH 4153                              NOL-DO  112-1657959-2/1/1
    62ICA72   865285116164/XELODA 500 MG
                        12-MAR-2008                        UNAPPROVED

    Roche Pharma
    Reinach , CH 4153                              NOL-DO  112-1657959-2/1/2
    62ICA72   865285116164/XELODA 150 MG
                        12-MAR-2008                        UNAPPROVED

    Swiss Beauty Concept Ltd
    Geneva 6 , CH                                  NYK-DO  112-1440742-4/1/1
    66PBL99   SUNSCREEN SPF 30, CHRONO REPAIR SOLAIRE EMULSION
                        25-MAR-2008                        NOT LISTED