Fujisawa Wins Back Rights In USA

Fujisawa USA, the Japanese drug company Fujisawa's US arm, has won back the right to seek federal approval for new products it wishes to market in the USA. Two years ago, the US Food and Drug Administration stopped Fujisawa from doing so as a result of charges that the US affiliate of the company had falsified applications and kept inaccurate records when seeking approval for new drugs.

The investigation which followed focused on Fujisawa's US generic drugs division Lyphomed, which it acquired in 1990. The data that was being investigated by the FDA came from Lyphomed in the 1980s.

Meantime, Fujisawa president Yoshihiro Horiguchi has said that the changes taking place in the US market have not affected the company's business there, reports Pharma Japan. Fujisawa is currently looking at whether to establish R&D functions in the USA following the successful launch of its immunosuppressant Prograf (tacrolimus).