ERWINASE- asparaginase injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASPARAGINASE ERWINIA CHRYSANTHEMI (UNII: D733ET3F9O) (ASPARAGINASE - UNII:G4FQ3CKY5R)

Available from:

Porton Biopharma Limited

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

ERWINASE- ASPARAGINASE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
PORTON BIOPHARMA LIMITED
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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HEALTH CARE PROVIDER LETTER
25 May 2021
IMPORTANT PRESCRIBING INFORMATION
Subject: Temporary importation of Erwinase (crisantaspase) injection,
powder,
lyophilized, for solution to address a drug shortage in the United
States (U.S.)
DEAR HEALTHCARE PROFESSIONAL,
In order to alleviate a critical shortage of U.S.-licensed
asparaginase erwinia
chrysanthemi injection, powder, lyophilized, for solution in the US
market, Porton
Biopharma Limited (PBL) is coordinating with the U.S. Food and Drug
Administration
(FDA) to make available in the U.S. the non-FDA licensed Erwinase
(crisantaspase)
10,000 IU/vial powder for solution for injection/infusion.
At this time, no other entity except PBL (via its distributor Clinigen
Inc.) is authorized by
the FDA to import and distribute Erwinase in the U.S. However, this
does not represent
a formal FDA approval of Erwinase in the U.S.
Effective immediately, PBL (via its distributor Clinigen Inc.) will
distribute the following
presentation of Erwinase (Batch number: W060172) to address the
critical shortage:
PRODUCT NAME PACK
SIZE
DESCRIPTION
U.K.
MARKETING
AUTHORIZATION
NUMBER
NDC
Erwinase,
10,000 IU/vial,
Powder for
solution for
injection/infusion.
5
vials
Powder for
solution for
injection/infusion.
White lyophilised
powder in a vial.
PL
44403/0002
NDC
81561-
413-
05*
*This NDC code has been assigned by PBL. The code is presented on the
carton. It
should be noted that the importer and distributor in the U.S. will be
Clinigen Inc. The
same NDC code will be used throughout the distribution chain of the
product in the U.S.
IT IS IMPORTANT TO NOTE THE FOLLOWING:
ERWINASE IS AVAILABLE IN THE U.S. ONLY BY PRESCRIPTION.
THERE IS NO BARCODE ON THIS PRODUCT FOR USE WITH U.S. BARCODE SCANNING
SYSTEMS.
Alte