IA#66-43 --- 12/6/88
TYPE OF ALERT: AUTOMATIC DETENTION
PRODUCT : Investigational New Drug
PRODUCT CODE : 66[][][][][]
PROBLEM : Unapproved use of toxic investigational new drug
PAC : 56008H
COUNTRY : All
MANUFACTURER/
SHIPPER : All
CHARGE : "The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to be a new drug within
the meaning of 201(p), without an approved new drug
application pursuant to Section 505(a)."
RECOMMENDING
OFFICE : Division of Drug Labeling Compliance (HFD-310)
Office of Compliance
REASON FOR
ALERT : Although Alzheimer's disease is clearly a serious disease, the
Commissioner stated at a July 28, 1988, meeting that FDA would
not exercise its discretion to allow patients to import "THA"
for their personal use under the newly instituted mail import
policy. This is because "THA" is known to be a potent
hepatotoxin, and widespread exposure to the drug could result
in many cases of serious liver injury. We have been advised
by the Division of Neurological Drug Products that a problem
exists in the recruitment of people for these active IND's
because of the large amounts of "THA" currently being imported
illegally.
INSTRUCTIONS : Automatically detain all shipments of the unapproved
investigational new drug, "THA" to determine if it is covered
by a currently active IND.
The following is a list of other names under which the drug
may be entering the country:
* Tetrahydroaminoacridine
* 1,2,3,4 Tetrahydro-5 Aminoacridine
* 5-Amino-1, 2, 3,4 Tetrahydroacridine
* 1,2,3,4 tetrahydro-9-Acridinamine
* 9-Amino-1,2,3,4 Tetrahydroacridine
* Tacrine
* Robotal
FOI : This import alert requires no purging
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