FDA Label for Cefotaxime

Important Prescribing Information

July 09, 2019

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 Apollo Pharmaceuticals USA Inc. (Apollo) and FFF Enterprises (FFF), 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 Apollo or its distributor FFF is authorized by the FDA to import or distribute SteriMaxs Cefotaxime for Injection in the United States. FDA has not approved SteriMaxs Cefotaxime for Injection in the United States.

Effective immediately, FFF will distribute the following presentations of SteriMaxs Cefotaxime for Injection to address the critical shortage:

Note: DIN refers to Drug Identification Number for products approved by Health Canada

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 should be followed to assure that the correct drug product is being used and administered to individual patients.

In addition, the packaging of the imported product does not include serialization information. SteriMax’s Cefotaxime for Injection does not meet the Drug Supply Chain Security Act (DSCSA) requirements for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs

The vial and carton labels will display the text used and approved for marketing the products in Canada with both English and French translations. It is important to note that there are differences in the format and content of the labeling between the US approved product and SteriMax’s Cefotaxime for Injection.  Please see the product comparison tables at the end of this letter.

Cefotaxime for Injection is available only by prescription in the U.S.Please refer to the package insert for the FDA-approved Cefotaxime for Injection drug product for full prescribing information.

Finally, please ensure that your staff and others in your institution who may be involved in the administration of Cefotaxime for Injection receive a copy of this letter and review the information.

If you have any questions about the information contained in this letter, any quality related problems, or questions on the use of SteriMax’s Cefotaxime for Injection, please contact SteriMax Inc. Customer Service at 1-800-881-3550.

To place an order, please contact FFF Enterprises at1-800-843-7477.

Healthcare providers should report adverse events associated with the use of SteriMax’s Cefotaxime for Injection to Apollo at 1-833-727-6556.

Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call

1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

We remain at your disposal to answer any questions you may have about our product; and provide more information if needed.

Sincerely,

James Booker

Head of Quality

SteriMax Inc.

Cefotaxime For Injection - 1 G Per Vial

Sterile/Stérile DIN 02234091

cefoTAXime sodium for Injection BP

1 g per vial

Cefotaxime sodium powder for solution

Intramuscular or Intravenous Use

Antibiotic/Antibiotique

LATEX FREE/SANS LATEX

STERIMAX

1gvial - 1gvial

Cefotaxime For Injection - 2 G Per Vial

Sterile/Stérile DIN 02434105

cefoTAXime sodium for Injection BP

2 g per vial

Cefotaxime sodium powder for solution

Intramuscular or Intravenous Use

Antibiotic/Antibiotique

LATEX FREE/SANS LATEX

STERIMAX

2gvial - 2gvial