Registration of generic alternatives to praziquantel for the control of Taenia ovis

Abstract

Extract

Taenia ovis is a parasite which infects dogs (the definitive host) and sheep and goats (intermediate hosts). It has been the subject of a control programme in New Zealand based largely on the 6-weekly dosing of rural dogs with praziquantel. Since the patent for praziquantel has expired, various generic formulations have become available, including the formulation tested here. It is debatable whether such products should be tested for bioequivalence and biological activity against the target parasite or for bioequivalence only. In this instance, although the drug had been registered on the basis of blood levels of praziquantel achieved, it was felt that a biological test would be beneficial if the generic drug, mixed with other anthelmintics, was to be used on a wide scale to control Taenia ovis in New Zealand.