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U.S. Department of Health and Human Services

Import Alert 66-44
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 66-44
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Foreign Manufactured Unapproved Versions Of Clozapine (Clozaril)"

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 1(B)       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. 1(B)                                                                 Clozapine (Clozaril), an a typical 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.

Guidance:
Districts may detain, without physical examination, 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 9-1 is not appropriate because the use of such drug could POSE A HEALTH HAZARD AND RISK TO THE SAFETY OF THE USER.

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

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)."

OASIS Charge Code - UNAPPROVED

Countries

MULTIPLE COUNTRIES (PODS ONLY)
(65 V - - 13) Clozapine (Sedative)
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