R-PR'S DILACOR XR APPROVED IN USA

Franco-American pharmaceutical concern Rhone-Poulenc Rorer has received approval from the US Food and Drug Administration to market its once-daily version of the generically available calcium channel blocker diltiazem. The product, which is indicated for the treatment of hypertension, will be marketed under the name Dilacor XR.

The approval follows closely on from the announcement that R-PR and generics specialist Bolar Pharmaceutical are to restructure their existing agreement concerning the marketing of diltiazem in the USA. Under the new deal, Bolar will assume sole responsibility for marketing of an immediate-release formulation of diltiazem while R-PR takes responsibility for the marketing, manufacturing and clinical development of Dilacor XR.

The immediate-release form of diltiazem is still awaiting approval from the FDA. Bolar will retain all profits on sales of this form once approval is received, and both companies will share profits on Dilacor XR sales. However, as R-PR has given up rights to the immediate-release formulation, it will receive "additional consideration" on Dilacor XR profits.