As part of the review, the APVMA asked the single registrant, Boehringer Ingelheim Pty Ltd, to provide more information and data to support the continued use and registration of the only clanobutin sodium product on the market, Bykahepar Digestive Stimulant. These data were required to address toxicological concerns and to establish an ADI and MRLs for food-producing animals.
In 1998, the review was suspended because the registrant of Bykahepar Digestive Stimulant indicated that they would not provide the data necessary to complete the residues assessment and that they would not be renewing the registration of their product.
In 1998, the registration of Bykahepar Digestive Stimulant was transferred to another registrant, Schering-Plough, which renewed the registration of the product. At that time, the APVMA reactivated the review because the original concerns about residues had not been adequately addressed.