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IA#66-44,  Revised 4/27/93

TYPE OF ALERT   :  AUTOMATIC DETENTION

PRODUCT         :  Clozapine (Clozaril) - Unapproved Foreign
                   Manufactured Version of the NDA Approved Sandoz
                   Drug.

PRODUCT CODE    :  66 [] [] [] []

HARMONIZED
CODE            :  N/A

PROBLEM         :   Unapproved Foreign Manufactured Versions of the
                   NDA Approved Sandoz Drug Which MAY POSE SERIOUS
                   AND LIFE THREATENING ADVERSE REACTIONS (DRND)

COUNTRY         :  ALL

MANUFACTURER/
SHIPPER         :  ALL

MANUFACTURER
SHIPPER I.D.#   :  N/A

IMPORTER'S
I.D.#           :  N/A

CHARGE          :  The article is subject to refusal of admission
                   pursuant to Section 801(a)(3) in that it appears
                   to be a new drug without an effective new drug
                   application (NDA) as required by Section 505(a).

RECOMMENDING
OFFICE          :  Prescription Drug Compliance Branch
                   Division of Drug Labeling Compliance (HFD-313)

REASON FOR
ALERT            : The Divisions of Neuropharmacological Drug
                   Products (HFD-313) and Drug Labeling Compliance
                   (HFD-313) reported that Clozapine (Clozaril)
                   manufactured by sources other than Sandoz may
                   be entering the United States for personal use.
                   The drug is the subject of an approved New Drug
                   Application (NDA) and is marketed in the U.S. by
                   Sandoz Pharmaceuticals Corporation, East
                   Hanover, New Jersey.  Clozapine (Clozaril), an
                   atypical antipsychotic drug, is associated with
                   a number of SERIOUS ADVERSE DRUG REACTIONS
                   including agranulocytosis, seizure, hypothermia,
                   and tachycardia.


                   FDA has concluded that unapproved Clozapine
                   (Clozaril) would be inappropriate for release
                   under the personal importation guidance,
                   Regulatory Procedures Manual (RPM) chapter 9-71
                   "Coverage of Personal Importations" (12/11/89),
                   because the intended use of such drug could POSE
                   A HEALTH HAZARD AND RISK TO THE SAFETY OF THE
                   USER.

INSTRUCTIONS    :  Automatically detain all shipments (commercial
                   and personal) of foreign manufactured
                   unapproved versions of the drug "Clozapine"
                   (Clozaril). Districts should determine whether
                   the drug is covered by a current approved NDA or
                   IND.  Discretionary release of this drug under
                   the Personal Importation guidance of RPM Chapter
                   9-71 is not appropriate because the use of such
                   drug could POSE A HEALTH HAZARD AND RISK TO THE
                   SAFETY OF THE USER.

PRIORITIZATION
GUIDANCE        :  N/A

FOI             :  No purging is necessary.

KEYWORDS        :  Clozapine, Clozaril, Unapproved New Drug
                   Application, NDA, Personal Importation

Prepared by     :  Marvin A. Blumberg, DIOP, (301) 443-6553