IA #62-07 - 12/14/01, IMPORT ALERT #62-07, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF SHIPMENTS OF SYGEN INJECTABLE (BOVINE-EXTRACTED GMI
MONOSIALOGANGLIOSIDE)"
TYPE OF ALERT: Detention without Physical Examination (DWPE)
NOTE: This import alert contains the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or product(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.
PRODUCT: Sygen, injectable
PRODUCT CODE: GPI=DI, DE, BI, DR [past entry information has shown that
numerous types of product codes have been used including
those for devices, biologics, etc.]
PROBLEM: Unapproved new drug
Possible contamination with the infectious agent for Bovine
Spongiform Encephalopathy (BSE)
Failure to meet Drug GMP's
PAF: AAP-Approvals
DRT-drug testing
PAC: 56008H
56R844
COUNTRY: All (ZZ)
MANUFACTURER/
SHIPPER: All, except certain shipments from Fidia SpA, Padua, Italy (FEI
#3002806986) as explained below under GUIDANCE.
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a new drug that is
adulterated, misbranded, or without an effective new drug
application (NDA) as required by Section 505. [Unapproved new
drug, Section 505(a)]."
and
"The article is subject to refusal of admission pursuant to
Section 801(a)(1) in that it appears to be for use as a drug and
may have been manufactured, processed, or packed under insanitary
conditions, or the article appears to be prepared, packed, or held
under insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to
health [Adulterated drug, Section 501 (a)(2)(a)]."
and
"The article is subject to refusal of admission pursuant to
Section 801(a)(1) in that it appears to be for use as a drug and
may not have been manufactured, processed, packed, or held in
conformity with current good manufacturing practices [Adulterated
drug, Section 501 (a)(2)(B)]."
OASIS CHARGE
CODE: UNAPPROVED, BSE DRUGS, DRUG GMPs
RECOMMENDING
OFFICE: CDER, OC, Division of Prescription Drug Compliance and
Surveillance (HFD-330), and CDER, OC, Manufacturing and Product
Quality (HFD-320)
REASON FOR
ALERT: Sygen is an unapproved new drug manufactured by Fidia SpA, Italy,
which is currently distributed under ^ ^. The
product presents BSE concerns because it is manufactured from
bovine brain starting material. An inspection of Fidia conducted
in February - March 2001, disclosed significant deficiencies
regarding verification that the bovine brain source used in the
manufacture of Sygen was obtained from a non-BSE country or that
no commingling with any animal material from BSE risk countries
had occurred. A Warning Letter was issued on June 28, 2001, to
Fidia and CDER/OC is awaiting response.
The Office of Compliance has also learned that firms other than
Fidia SpA are shipping Sygen to the U.S. Two such firms include
TRB-Pharma of Brazil and its subsidiary, TransBussan of
Switzerland. Neither of these firms has approved IND's for Sygen.
Reportedly, the shipments are being offered for entry for personal
treatment under FDA's procedures for Coverage of Personal
Importations.
GUIDANCE: Districts may detain without physical examination all shipments of
Sygen unless:
-they are coming directly from Fidia SpA, Padua, Italy;
and
-they are from finished product lot nos. ^
<<< and active pharmaceutical ingredient (API) lot no. ^^ and active pharmaceutical ingredient (API)
lot no. >>> 010000
^
and
-they are offered for entry under ^
^
Districts encountering shipments of Sygen, which meet the listed
criteria, should contact Muralidhara (Mike) Gavini at 301-827-7277
for further instructions.
For questions concerning the new drug status of the product,
please contact Ada Irizarry at 301-827-7324.
Discretionary release of Sygen injectable under the Personal
Importation guidance of Chapter 9 of the Regulatory Procedures
Manual (RPM) is not appropriate. This drug poses an unreasonable
health risk to the user due to possible exposure to Bovine
Spongiform Encephalopathy (BSE) causative agents.
FOI: Purging is required between ^ ^
KEYWORDS: Sygen, Monosialoganglioside, GMI, BSE, Unapproved New Drug
PREPARED
BY: Stella Notzon, DIOP, 301-443-6553.
DATE LOADED
INTO FIARS: December 14, 2001
Attachment to Import Alert #62-07 12/14/01
Known Sygen Distributors:
TransBussan S.A.
12 Rue Michel-Servet
P.O. Box 352
Geneva, Switzerland
FEI # 1000201468
Trb Pharma
Rua Hildebrando Siqueira
149-Americanopolis
Sao Paulo, Brazil CEP 04334-150
FEI # 3002574371
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