JAPANESE REGULATORS GRANT APPROVALS TO BAYER, ASTELLAS, CHUGAI

The Japanese Ministry of Health, Labor and Welfare has approved Bayer Schering Pharma's long-acting intrauterine contraceptive system Mirena, the company announced. The product is expected to be launched in Japan in April.

The approval is based on broad experience from international studies as well as a Japanese study program, including a large clinical trial with more than 400 Japanese women. The product has been used by more than 10 million women worldwide and is registered in more than 100 countries, according to Bayer. With the approval in Japan, Mirena is now available in all major pharmaceutical markets, the company said.

Mirena is a levonorgestrel-releasing intrauterine contraceptive system. The product does not contain estrogen, but instead it delivers a low dose of the progestin levonorgestrel.

In addition, Astellas Pharma announced it has received Japanese approval for its candin antifungal agent Funguard (micafungin sodium) for the prophylaxis of Aspergillus and Candida infections and for the immunosuppressant Prograf (tacrolimus) for treating lupus.

Lastly, Chugai Pharmaceutical, in partnership with Roche, announced that the antiviral Copegus (ribavirin) has been approved in Japan for use in combination with Pegasys to treat hepatitis C.