Galen Holdings has moved one step closer to achieving its ambition of launching a hormone delivery product in the lucrative American market. The Northern Ireland specialty pharmaceutical group announced yesterday that it had completed the submission of a new drug application to the US Food and Drink Administration for an intravaginal ring (IVR) estrogen replacement therapy. The product, which will be marketed under the brand name Estrace, delivers hormone replacement therapy for women, particularly those who have undergone a hysterectomy. The registration process in the US is likely to be completed within the next 12 months and the product could then be launched in the American market by early 2003.