Recent Japanese drug approvals for multinationals

April saw three drugs developed by non-Japanese companies receiveapproval from Japan's regulatory authority, according to Pharma Japan. These were:

- Pharmacia's Zyvox (linezolid) injection and tablets, for the treatment of infections caused by vancomycin-resistant Enterococcus faecium. It is said to be the first drug to be approved in Japan for VRE infections. Zyvox was cleared for marketing in the USA a year ago and achieved sales there of $48 million in 2000. It was also approved in the UK earlier this year (Marketletter February 12) and is being reviewed under the European Union's mutual recognition procedure;

- Eli Lilly's Gemzar (gemcitabine) for the treatment of pancreatic cancer. This drug has previously been approved in 99 countries for indications such as pancreatic cancer and for use in-small cell lung cancer, as well as in Europe as a bladder cancer therapy (Marketletters passim), with worldwide sales reaching $559.3 million in 2000; and