SFDA Suspends Registration and Recalls RABEZOLE Product due to its Lack of Bioequivalence with the Reference Product

The Saudi Food and Drug Authority (SFDA) has issued a decision to recall and suspend the registration of the product (RABEZOLE) for the two registered strengths of 20 mg and 10 mg, (Registration No 95-368-07 and 96-368-07). The products are marketed by Jamjoom Pharmaceuticals. The decision has been taken as the product was found to be not bioequivalent with the reference product.

SFDA stated that bioequivalence study is a study that is conducted according to internationally recognized scientific standards to verify that there are no differences between the generic product (similar) and the reference product in terms of rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action when used in the same dose.

SFDA requested the health authorities to withdraw the two products if they were available, also addressed the marketing company to withdraw them from market and called on all patients who are taking the product to visit their healthcare provider to be given an alternative product.

SFDA circular came based on the decision of the Committee of Registration of Pharmaceutical Companies and Factories Products No. (43/sfda/1107/23) to suspend the registration and withdrawal of the two products.