Health Canada says the move comes from concerns over bioequivalence test data, which is used to show that a pharma company's generic prescription drug works the same as the brand-name counterpart.Posted: Jun 08, 2024 2:27 PM EDT | Last Updated: 38 minutes ago
Accel Pharma's ondansetron tablets are among those being recalled due to concerns over efficacy test data. Health Canada says the move comes from concerns over bioequivalence test data, which is used to show that a pharma company's generic prescription drug works the same as the brand-name counterpart. Three pharmaceutical companies are recalling various tablets due to concerns about the tests used to demonstrate their efficacy, Health Canada announced.Accel-Ondansetron ODT .
Specifically, the agency says the tests for the three companies were conducted by India-based Synapse Labs, which the European Medicines Agency determined could not be relied upon."At Health Canada's request, the companies have stopped sale and have recalled all lots of the affected products until they can provide additional information to demonstrate that the products are safe and effective.
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