“SFDA” Suspends and Withdraws the Registration of (LORA S Tablet) and (LORINASE Tablet)2021-03-25
The Saudi Food & Drug Authority (SFDA) has announced the withdrawal and suspension of registration of the pharmaceutical product (LORA S Tablet, batch number (8-968-15)) and (LORINASE TABLETS, batch number (250-212-09) ).
SFDA added that (LORA S Tablet) is marketed by Dammam Pharma Company, whether the other product (LORINASE Tablet)
It has withdrawn the medicine from the Kingdom, and suspended its registration due to the medicine’s non-bio equivalence to the second brand.
Bioequivalence is conducting based on international scientific standards to assure there are no differences between generic drugs and second brands in efficacy and absorption when using it at the same dose.
The Authority addressed health authorities to withdraw the mentioned products as soon as it is available, calling on patients to contact their doctors to receive the alternative medication.
The Authority’s circular based on the decision of the registration of pharmaceutical companies and their products Committee (No 18/1061/sfda/42), to suspend the registration and withdrawal the product.