Withdrawal of two generic clopidogrel products in Saudi Arabia for non-bio-equivalence

To the Editor: Clopidogrel, a P2Y12 platelet inhibitor, is indicated for the treatment of cardiovascular and cerebrovascular events.1–3 In February 2018, the Saudi Food and Drug Authority (SFDA) announced the withdrawal of two locally approved clopidogrel generic products (Pedovex and Cardlet), secondary to failure in demonstrating bioequivalence to the reference product (Plavix). With this action, the SFDA has reconfirmed that annual post-marketing surveillance is a continuous ongoing process that ensures that all marketed products are up to standards