MMD RECEIVES FDA OK FOR RIFATER

Marion Merrell Dow has received clearance from the US Food and Drug Administration to market Rifater (rifampin, isoniazid, pyrazinamide), the only triple-combination product available for daily therapy during the initial two-month intensive treatment phase of pulmonary tuberculosis.

Rifater, which will be launched this summer, combines three drugs recommended by the Centers for Disease Control and Prevention as a principal part of short-course therapy. It is the first new product approved for TB in the USA in 19 years. The approval comes one year after MMD submitted the New Drug Application to the agency, following the FDA's "encouragment" of MMD to seek US marketing approval.

Historically, the short-course treatment of tuberculosis called for multiple drugs taken several times daily. The combination of the drugs should allow for a greater compliance within the high-risk community by reducing the number of tablets by half. Poor compliance, besides lessening the efficacy of the treatment, can lead to the development of drug-resistant TB, a problem which could easily be exacerbated by the large recent rise in TB cases in the USA over the past decade due to factors such as large concentrated slum areas and the increasing number of AIDS cases in these areas. In 1993, 28,000 new cases of TB were reported. In some parts of New York patients who repeatedly fail to complete their drug course for TB infection can be forcibly held in isolation until the disease is properly treated.