Columbia Files NDA For Crinone In USA

Columbia Laboratories has filed a New Drug Application in the USA for Crinone, its locally-delivered progesterone gel for the treatment of patients with secondary amenorrhea, which avoids the side effects seen with orally-delivered progesterone.

Crinone is the first product to deliver progesterone directly to the uterus, and was launched in its first market, the UK, in June 1995 for a broad range of indications, including; the prevention of hyperplasia and endometrial cancer in postmenopausal women receiving hormone replacement therapy, use in in vitro fertilization procedures, infertility due to inadequate progesterone production, reduction of the symptoms of premenstrual syndrome, menstrual irregularities, dysmenorrhea and dysfunctional uterine bleeding.

Crinone has also been approved for marketing in Ireland and Finland for the above indications and in France for in vitro fertilization procedures. Other European and Scandinavian approvals are expected before year-end. In the USA, Columbia has completed trials of the product in assisted reproduction and will file for approval of this indication later in the year.