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


    Novaris Pharama Schweiz Ag
    Postfach , CH                                  NOL-DO  112-8117169-6/1/1
    63XIS99   859011972759  LETROZOLE
                        28-JAN-2008                        UNAPPROVED

    Isispharma
    Bahnof , CH 3900                               NOL-DO  112-7501451-4/2/1
    64XAO99   861494707399 / UNITONE
                        28-JAN-2008                        NOT LISTED

    Isispharma
    Bahnof , CH 3900                               NOL-DO  112-7501451-4/2/2
    64XAO99   861494707399  Xerolys 50
                        28-JAN-2008                        NOT LISTED
                                                           DRUG NAME
                                                           UNAPPROVED

    Isispharma
    Bahnof , CH 3900                               NOL-DO  112-7501451-4/2/3
    62LDO40   861494707399  MetroRuboril (METRONIDAZOLE)
                        28-JAN-2008                        NOT LISTED
                                                           LACKS N/C
                                                           UNAPPROVED