FDA Label for Cisplatin

Important Prescribing Information

May 24, 2023

Subject: Temporary Importation of CISplatin Injection with non-U.S. Labeling to Address Drug Shortage

Dear Healthcare Professional:

Due to the critical shortage of CISplatin Injection in the United States (U.S.), Qilu Pharmaceutical Co. Ltd (Qilu), in conjunction with Apotex Corp., is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. Qilu has initiated temporary importation of CISplatin Injection (50 mg/50 mL) with vial and carton labels in Chinese into the U.S. market. The CISplatin Injection from Qilu is marketed and manufactured in China and is not FDA-approved.

Only Qilu or its distributor, Apotex Corp., is authorized by the FDA to import or distribute Qilu's CISplatin Injection in the United States.

Effective immediately and during this temporary period, Apotex Corp. will distribute the following presentation of CISplatin Injection to address the critical shortage:

It is important to note the following:

• The carton labeling and container label did not include the warning statements, “Stop! Verify Drug Name and Dose!” or “CISplatin doses greater than 100 mg/m ² once every 3 to 4 weeks are rarely used”. Thus, a sticker containing this warning statement, the name of the product, strength, concentration, U.S. NDC number and linear barcode has been applied to the vial and the carton.
• The container label did not have the translated name of the product “CISplatin”. Thus, a sticker containing the information noted in the bullet above has been applied to the vial.
• Drug- drug interaction with bisulfite, metabisulfite, sodium bicarbonate and fluorouracil.
• The product is colorless to yellowish clear liquid.
• The vial and carton labels will display the text used and approved for marketing the products in China containing Chinese only text. Example images of this labeling are provided in Appendix 2.
• There are differences in the format and content of the labeling between the FDA-approved product and Qilu’s CISplatin Injection. Please see the product comparison table in Appendix 3 and corresponding English translations.

CISplatin injection is available only by prescription in the U.S. . The imported lots did not have the statement “Rx only” on their labeling. Thus, a sticker containing the information noted in the bullet above has been applied to the vial and the carton.

The linear barcode on the imported product label may not register accurately on the U.S. scanning systems. Institutions should manually input the imported product information, including the NDC, into their systems and confirm that the linear 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 carton of the imported product does not include a product identifier as required under the Drug Supply Chain Security Act (DSCSA). Specifically, each package of product does not include the NDC, unique serial number, lot number, and expiration date in both human-readable form and a two-dimensional data matrix barcode.

Please refer to the package insert for the FDA-approved CISplatin 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 CISplatin 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 Qilu’s CISplatin Injection, please contact Apotex Corp. Customer Service at 1-800-706-5575.

For ordering information, please contact your primary wholesaler or distributor to place an order with Apotex Corp. at 1-800-706-5575.

Healthcare providers should report adverse events associated with the use of Qilu’s CISplatin Injection to Apotex Corp. at 1-800-706-5575.

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,

sign - sign

Mr. Yin Xunliao

Deputy General Manager

Qilu Pharmaceutical Co., Ltd.

Enclosures:

Appendix 1 – Barcodes for Pharmacy Dispensing

Appendix 2 – Product Label and Product Characteristics Side-by-Side Comparison Table

Appendix 3 – Prescribing Information Side-by-Side Comparison Table

Available at www1.apotex.com/us/CISplatin Injection

Appendix 1: Barcode for Pharmacy Dispensing

Appendix 2: Product Label and Product Characteristics Side-by-Side Comparison Table

Appendix 3: Prescribing Information Side-by-Side Comparison Table (translated from Chinese)

Cisplatin Injection (50 Mg/50 Ml)

NDC 60505-6277-0

Stop! Verify Drug Name and Dose!

CISplatin Injection

50 mg/50 mL (1 mg/mL). Rx Only.

CISplatin doses greater than 100 mg/m ²

once every 3 to 4 weeks are rarely used. See letter.

sticker - sticker