IA #66-49, REVISED 1/5/07, "DETENTION WITHOUT PHYSICAL EXAMINATION OF ALL
POLIDOCANOL FINISHED DOSAGE FORM PRODUCTS AND ACTIVE PHARMACEUTICAL
INGREDIENTS (APIS) FROM ALL SOURCES UNDER ALL BRAND NAMES INCLUDING
AETOXISCLEROL, AETHOXYSKLEROL, AND SCLEROVEIN"
TYPE OF ALERT: Detain Without Physical Examination (DWPE)
NOTE: *** This revision updates the charges which apply to
this import alert. It also broadens the scope of the alert
to include importations from all countries and
manufacturers. Changes appear between asterisks. ***
(This import alert represents 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: Polidocanol - also known as
* Aetoxisclerol 0.5%
* Aethoxysklerol injection 1% and 3%
* Sclerovein 5%
PRODUCT CODE: 65U[][]04, 65U[][]99
PROBLEM: Unapproved New Drug (DNRD), *** Misbranded Drug ***
PAC FOR: 56008H
COUNTRY: *** All ***
MANUFACTURER/
SHIPPER: *** All ***
CHARGES: For finished drug products:
"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 (NDA). [Unapproved new drug, section 505(a)]"
CHARGE CODE: UNAPPROVED
*** For active pharmaceutical ingredient intended for
pharmacy compounding:
"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to be misbranded
because it lacks adequate directions for its intended use.
[Misbranding, Section 502(f)(1)]." CHARGE CODE: DIRECTIONS
For products labeled in language other than English:
"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to be misbranded
because it lacks an English language label. [Misbranding,
Section 502(c]." *** CHARGE CODE: NO ENGLISH
RECOMMENDING
OFFICE: CDER, Office of Compliance
REASON FOR
ALERT: Drugs containing polidocanol are brought into the U.S. by
private physicians for the treatment of spider veins. No
products containing polidocanol are currently approved for
marketing in the United States. Aetoxisclerol, manufactured
by Laboratoires Parmacetiques, has been identified as
labeled solely in French.
*** CDER has new information that polidocanol finished
dosage form products are being imported from additional
countries, and that the API is being imported for use in
pharmacy compounding. Polidocanol is not an active
ingredient contained in any FDA-approved drug product, and
FDA does not sanction its use in pharmacy compounding. ***
GUIDANCE: *** Districts may detain without physical examination, all
shipments of polidocanol finished dosage products and APIs
from all sources. [Note: Shipments of polidocanol that are
covered under existing active INDs are not subject to this
IA.] ***
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging required
KEYWORDS: Polidocanol, Aetoxisclerol, Aethoxysklerol, Sclerovein,
Unapproved New Drug, NDA, Misbranded
CDER contact: Ada Irizarry, HFD-310, 301-827-8930
PREPARED BY: William G. Nychis, CDER, HFD-310, 301-827-8959
Anthony W. Lee, DIOP, HFC-170, 301-443-6553
Date Loaded
Into FIARS: January 5, 2007
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