APO-VARENICLINE
APO-VARENICLINE- varenicline
APO-VARENICLINE- varenicline tartrate tablet, film coated
Apotex Corp
HEALTH CARE PROVIDER LETTER
IMPORTANT PRESCRIBING INFORMATION
July 2, 2021
Apotex Corp.
2400 N Commerce Parkway
Suite 400
Weston, FL 33326
Phone: 1-800-706-5575
| Subject: Importation of Apotex Inc.’s Canadian approved Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg (based on free base equivalents) Tablets to Address Drug Shortage |
Dear Healthcare Professional:
In order to alleviate a critical shortage of CHANTIX® (varenicline tartrate) tablets 0.5 mg and 1 mg in the United States (U.S.) market for the indicated use as an aid to smoking cessation, Apotex Corp. is coordinating with the U.S. Food and Drug Administration (FDA) to temporarily import into the U.S. the non-FDA approved drug, Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg (free base equivalent) tablets to increase the availability of the drug. The varenicline tartrate tablets marketed in Canada under the name Apo-Varenicline by Apotex Inc. are approved by Health Canada as a generic equivalent to CHAMPIX® tablets manufactured by Pfizer Canada, Inc., and are manufactured in an FDA-inspected facility that complies with current Good Manufacturing Practice (cGMP) requirements.
At this time, no other entity except Apotex Corp. is authorized by the FDA to import or distribute Apotex Inc.’s Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg (free base equivalent) tablets in the U.S. However, this does not represent a formal FDA approval of Apotex Inc.’s Apo-Varenicline (varenicline tartrate) tablets in the United States.
Effective immediately, Apotex Corp. will distribute the following presentations of Apotex Inc.’s Apo-Varenicline (varenicline tartrate) tablets to address the critical shortage:
Table 1
| Product Name | Quantity | Tablet Description | U.S. NDC |
| Apo-Varenicline (varenicline tartrate) tablet, 0.5 mg (free base equivalent) | Bottle of 56 tablets | White colored, modified capsule-shaped, biconvex, film coated tablets, engraved with “APO” on one side and “VAR” over “0.5” on the other side. | 60505-4765-5 |
| Apo-Varenicline (varenicline tartrate) tablet, 1 mg (free base equivalent) | Bottle of 56 tablets | Blue colored, modified capsule-shaped, biconvex, film coated tablets, engraved with “APO” on one side and “VAR” over “1” on the other side. | 60505-4766-6  |
| Apo-Varenicline (varenicline tartrate) tablet, 0.5 mg and 1 mg (free base equivalent) | Starter Blister Pack of 53 tablets | 0.5 mg: White colored, modified capsule-shaped, biconvex, film coated tablets, engraved with “APO” on one side and “VAR” over “0.5” on the other side. 1 mg: Blue colored, modified capsule-shaped, biconvex, film coated tablets, engraved with “APO” on one side and “VAR” over “1” on the other side. | 60505-4767-0  |
| Apo-Varenicline (varenicline tartrate) tablet, 1 mg (free base equivalent) | Continuation Blister Pack of 56 tablets | Blue colored, modified capsule-shaped, biconvex, film coated tablets, engraved with “APO” on one side and “VAR” over “1” on the other side. | 60505-4766-5 |
1 CHAMPIX® is the brand name of CHANTIX® sold in Canada
The product container label will display the text that is approved for marketing the products in Canada with both official languages, English and French. It is important to note that there are differences in the format and content of the labeling between Apo-Varenicline (varenicline tartrate), whether 0.5 mg or 1 mg varenicline free base equivalent, and CHANTIX® (varenicline tartrate) tablets. Please see the product comparison tables at the end of this letter.
CHANTIX® (varenicline tartrate) tablets are available only by prescription in the U.S. Please refer to the package insert for CHANTIX® (varenicline tartrate) tablets for full prescribing information. Ensure that your staff and others in your office and/or pharmacy who may be involved in the prescribing and/or dispensing of Apo-Varenicline (varenicline tartrate) receive a copy of this letter, review the information and instruct patients on the differences between CHANTIX® (varenicline tartrate) and Apo-Varenicline (varenicline tartrate).
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. Barcodes for the U.S. NDCs for product identification are provided in Table 1 and Appendix 1 to assist with input into institutional systems.
In addition, Apotex Inc.’s Apo-Varenicline (varenicline tartrate) does not meet the product identifier requirements of the Drug Supply Chain Security Act (DSCSA) for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs. Apo-Varenicline (varenicline tartrate) blister packs are not child resistant.
If you have any questions about the information contained in this letter, any quality related problems, or questions on the use of Apotex Inc.’s Apo-Varenicline (varenicline tartrate), 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 Apotex Inc.’s Apo-Varenicline (varenicline tartrate) 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 preaddressed 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 to provide more information if needed.
Sincerely,
Kiran Krishnan, PhD
Senior Vice President, Global Regulatory and Medical Affairs
Apotex Corp.
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/apo-varenicline
Apo-Varenicline (varenicline tartrate),0.5 mg and 1 mg varenicline free base equivalent tablets product monograph: available at www1.apotex.com/us/apo-varenicline
Appendix 1: Barcodes for Pharmacy Dispensing
| Product Name | Quantity | NDC Barcode |
| Apo-Varenicline (varenicline tartrate) tablet, 0.5 mg (free base equivalent) | Bottle of 56 tablets | 60505-4765-5 |
| Apo-Varenicline (varenicline tartrate) tablet, 1 mg (free base equivalent) | Bottle of 56 tablets | 60505-4766-6 |
| Apo-Varenicline (varenicline tartrate) tablet, 0.5 mg and 1 mg (free base equivalent) | Starter Blister Pack of 53 tablets | 60505-4767-0 |
| Apo-Varenicline (varenicline tartrate) tablet, 1 mg (free base equivalent) | Continuation Blister Pack of 56 tablets | 60505-4766-5 |
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