If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  FDA Approves Eligard 7.5 mg (Leuprolide) for Prostate Cancer FORT COLLINS, CO -- January 24, 2002 -- Atrix Laboratories, Inc. announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) for Eligard™ 7.5 mg (leuprolide acetate) for subcutaneous injection for treatment of advanced prostate cancer. Atrix and Sanofi-Synthelabo Inc., Atrix's marketing partner for the Eligard product line, anticipates this new therapy will be an important addition in the fight against prostate cancer. Eligard 7.5 mg was formerly known as Leuprogel One-Month Depot. According to the American Cancer Society, prostate cancer is the most common cancer, excluding skin cancers, in American men. It is estimated that during the year 2002, approximately 189,000 new cases of prostate cancer will be diagnosed in the United States and an estimated 30,200 men will die of the disease. Approximately one man in six will be diagnosed with prostate cancer during his lifetime. Atrix is developing two additional Eligard products that release leuprolide acetate over a period of three and four months using Atrix's Atrigel® Depot drug delivery system. Sustained levels of leuprolide, a leutinizing hormone-releasing hormone (LHRH) agonist, decreases testosterone levels to suppress tumor growth in patients with hormone-responsive prostate cancer. The liquid Eligard products are injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed. In September, Atrix submitted a New Drug Application (NDA) for Eligard 22.5 mg (formerly Leuprogel Three-Month Depot) to the FDA and anticipates submitting an NDA for Eligard 30 mg (formerly Leuprogel Four-Month Depot) to the FDA in the first half of 2002. SOURCE: Atrix Laboratories, Inc.
|
