New CPAC Approvals Include Two NCEs

The Japanese Central Pharmaceutical Affairs Council recommendedapproval of 10 new products at its last meeting (on March 13), including the first HIV protease inhibitor to reach this stage in Japan, Merck & Co's Crixivan (indinavir sulfate).

The application for Crixivan was filed by Banyu which licenses the drug from Merck and will market it. Other HIV treatments to be cleared by the CPAC included Nippon Wellcome's Epivir (lamivudine) for use in combination with zidovudine, and Astra Japan's Foscavir (foscarnet sodium), for the treatment of cytomegalovirus retinitis in AIDS patients.

New Antibiotics The CPAC also approved two New Chemical Entity antibiotics. Suntory's Farom (fropenem sodium), an orally-active penem antibiotic, was approved in 150mg and 200mg tablets and will be marketed in Japan by Yoshitomi. Shionogi's Flomox (cefcapene pivoxil), an orally-active cephalosporin, was approved in 75mg and 100mg tablets for adult use, and 100 mg/g granules for pediatric use.