CEFOTAXIME- cefotaxime injection powder, for solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

CEFOTAXIME SODIUM (UNII: 258J72S7TZ) (CEFOTAXIME - UNII:N2GI8B1GK7)

MAH:

SteriMax Inc.

administration_route:

INTRAMUSCULAR

prescription_type:

PRESCRIPTION DRUG

authorization_status:

Unapproved drug for use in drug shortage

SPC

CEFOTAXIME- CEFOTAXIME INJECTION POWDER, FOR SOLUTION
STERIMAX INC.
_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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IMPORTANT PRESCRIBING INFORMATION
January 13, 2023
TEMPORARY IMPORTATION OF CEFOTAXIME FOR INJECTION TO ADDRESS DRUG
SHORTAGE
Dear Healthcare Professional:
Due to the current critical shortage of Cefotaxime for Injection
products in the United
States (U.S.) market, SteriMax Inc. (SteriMax), in conjunction with
Provepharm, Inc.
(Provepharm) and Direct Success, Inc. (Direct Success) is coordinating
with the U.S.
Food and Drug Administration (FDA) to increase the availability of the
drug. SteriMax has
initiated temporary importation of non-FDA approved Cefotaxime for
Injection (1 g/vial,
and 2 g/vial) into the U.S. market. The Cefotaxime for Injection from
SteriMax is
marketed in Canada and is manufactured at an FDA-inspected facility
that complies with
current Good Manufacturing Practice requirements.
At this time, no other entity except Provepharm or its distributor
Direct Success is
authorized by the FDA to import or distribute SteriMax’s Cefotaxime
for Injection in the
United States. FDA has not approved SteriMax’s Cefotaxime for
Injection in the United
States.
Effective immediately, Provepharm will distribute the following
presentations of
SteriMax’s Cefotaxime for Injection to address the critical
shortage:
Note: DIN refers to Drug Identification Number for products approved
by Health Canada
STERIMAX CEFOTAXIME FOR INJECTION
1 g/vial (as cefotaxime sodium)
DIN: 02434091
(Canada)
NDC 21586-011-2
2 g/vial (as cefotaxime sodium)
DIN: 02434105
(Canada)
NDC 21586-012-2
THE BARCODE ON THE IMPORTED PRODUCT LABEL MAY NOT REGISTER ACCURATELY
ON
THE U.S. SCANNING SYSTEMS. Institutions should manually input the
imported product
information into their systems and confirm that the barcode, if
scanned, provides
correct information. Alternative procedures s