FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Varenicline Tartrate (Chantix) Tablets
Status: Currently in Shortage
»Date first posted: 06/24/2021
»Therapeutic Categories: Analgesia/Addiction

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Apotex Corp. (New 07/16/2021)

Company Contact Information:
800-706-5575

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Apo-Varenicline 0.5 mg; bottle of 56 tablets (NDC 60505-4765-5) Available Apotex Corp., in coordination with the U.S. FDA, has initiated temporary importation of Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg tablets into the U.S. market to address a drug shortage of CHANTIX®. 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. CHAMPIX® is the brand name of CHANTIX® sold in Canada. Product is available via Apotex’s authorized distributors. Contact your primary wholesaler/distributor to place orders.

Dear Health Care Provider Letter

Apo-Varenicline 1 mg; bottle of 56 tablets (NDC 60505-4766-6) Available Apotex Corp., in coordination with the U.S. FDA, has initiated temporary importation of Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg tablets into the U.S. market to address a drug shortage of CHANTIX®. 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. CHAMPIX® is the brand name of CHANTIX® sold in Canada. Product is available via Apotex’s authorized distributors. Contact your primary wholesaler/distributor to place orders.

Dear Health Care Provider Letter

Apo-Varenicline 0.5 mg and 1 mg; Starter Blister Pack of 53 tablets; (NDC 60505-4767-0) Estimated Date Available; TBD Apotex Corp., in coordination with the U.S. FDA, has initiated temporary importation of Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg tablets into the U.S. market to address a drug shortage of CHANTIX®. 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. CHAMPIX® is the brand name of CHANTIX® sold in Canada. Product is available via Apotex’s authorized distributors. Contact your primary wholesaler/distributor to place orders.

Dear Health Care Provider Letter

Apo-Varenicline 1 mg: Continuation Blister Pack of 56 tablets (NDC 60505-4766-5) Estimated Date Available; TBD Apotex Corp., in coordination with the U.S. FDA, has initiated temporary importation of Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg tablets into the U.S. market to address a drug shortage of CHANTIX®. 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. CHAMPIX® is the brand name of CHANTIX® sold in Canada. Product is available via Apotex’s authorized distributors. Contact your primary wholesaler/distributor to place orders.

Dear Health Care Provider Letter

Pfizer Pharmaceuticals (Reverified 09/09/2021)

Company Contact Information:
800-533-4535

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Chantix 0.5 mg; bottle of 56 (NDC 0069-0468-56) Next Delivery and Estimated Recovery: TBD Shortage per Manufacturer: Product manufacturing and release delay due to product/ingredient testing Other
Chantix 1 mg; bottle of 56 (NDC 0069-0469-56) Next Delivery and Estimated Recovery: TBD Shortage per Manufacturer: Product manufacturing and release delay due to product/ingredient testing Other
Chantix Starting wallet; 0.5 mg 1x11 1 mg FCT 3x14 BLS WL US (NDC 0069-0471-03) Next Delivery and Estimated Recovery: TBD Shortage per Manufacturer: Product manufacturing and release delay due to product/ingredient testing Other
Chantix Continuing wallet; 1 mg FCT 4x14 BLS WL US (NDC 0069-0469-03) Next Delivery and Estimated Recovery: TBD Shortage per Manufacturer: Product manufacturing and release delay due to product/ingredient testing Other

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