Given the medical necessity of carbamazepine extended-release tablets and the need to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of USA-authorized Carbamazepine Extended-Release Tablets, USP manufactured by Ingenus Pharmaceuticals, LLC, with English-only labels, by Septa Pharmaceuticals Inc., to mitigate the shortage. The USA-authorized product has the same active ingredient (carbamazepine), strength (200 mg and 400 mg), dosage form (extended-release tablets), and route of administration (oral) as the Canadian-authorized product. However, there are differences in formulation and physical appearance between the USA-authorized and Canadian-authorized products. Healthcare professionals are advised to enhance their monitoring of the safety and effectiveness for the imported drug.
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