Presentation
Apo-Varenicline 0.5 mg; bottle of 56 tablets (NDC 60505-4765-5)
Apo-Varenicline 1 mg; bottle of 56 tablets (NDC 60505-4766-6)
Apo-Varenicline 0.5 mg and 1 mg; Starter Blister Pack of 53 tablets; (NDC 60505-4767-0)
Apo-Varenicline 1 mg: Continuation Blister Pack of 56 tablets (NDC 60505-4766-5)
Availability and Estimated Shortage Duration
Available
Available
Estimated Date Available; TBD
Estimated Date Available; TBD
Related Information
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.
Shortage Reason (per FDASIA)