"Detention Without Physical Examination of Shipments of Sygen Injectable (Bovine-Extracted GMI Monosialoganglioside)"

Sygen is an unapproved new drug manufactured by Fidia SpA, Italy, which is currently distributed under b(4)              . 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.

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. b(4)                    and active pharmaceutical ingredient (API) lot no. (B)1        

and

-they are offered for entry under b(4)                                                                                               
Districts encountering shipments of Sygen, which meet the listed criteria, contact for further instructions.

For questions concerning the new drug status of the product, please contact **CDER/Office of Compliance (OC), Imports Exports Compliance Branch. The CDER/OC/Imports Exports Compliance Branch can be contacted at cderimportsexports@fda.hhs.gov***

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.

Sygen, injectable

"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)]."

OASIS charge code - UNAPPROVED

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)]."

OASIS charge code - BSE DRUGS

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 - DRUG GMPS