Schering Gets OK For Hormone Drugs

The German health authorities have given Schering AG the go-ahead to continue marketing its two cyproterone acetate-based products, Diane 35 and Androcur 10, which had been suspected of having carcinogenic properties. However, labeling changes have been ordered by the Federal Institute for Drugs and Medical Devices.

Schering chairman Giuseppe Vita said he expects that the products will develop positively once the negative publicity surrounding them has dissipated. The allegations of carcinogenicity were put forward in August (Marketletter August 22) and, as a result, sales of the two drugs fell 3% in October compared to the previous year. However, Mr Vita noted that sales were up 12% in the first nine-months of 1994 compared to the like, year-earlier period.

The two products contribute more than 400 million Deutschemarks ($260 million) in annual sales for the group. Diane 35 is marketed for treating acne and facial hair in women, while Androcur 10 is a treatment for prostatic hypertrophy.