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| |  TAP's Lupron Depot - 3 Month 22.5 mg Cleared by FDA DEERFIELD, Ill., Jan. 17, 1996 -- TAP Holdings Inc., announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Lupron Depot - 3 Month 22.5 mg (leuprolide acetate for depot suspension) as a palliative treatment for advanced-stage prostate cancer. Because of the drug's long-acting formulation, patients will need only one injection of Lupron Depot - 3 Month 22.5 mg every 12 weeks to treat their condition. Prostate cancer is now the second leading cause of cancer deaths in American men. In 1995, the American Cancer Society estimated that 244,000 men were diagnosed with prostate cancer and that 40,400 died from the disease. "This is a significant benefit for men with advanced-stage prostate cancer," said E. David Crawford, M.D., Professor and Chairman, Division of Urology, University of Colorado Health Sciences Center. "Men will no longer have to visit their physician's office every month for an injection. It's a lot more convenient for the patients and it could lead to reduced overall treatment costs." Lupron Depot - 3 Month 22.5 mg works by shutting down the production of the hormone testosterone, which plays a significant role in the growth of prostate cancer. Decreasing the levels of testosterone in the body also alleviates the bone pain and urinary problems that may be associated with metastatic prostate cancer. In clinical trials, the safety and efficacy of Lupron Depot - 3 Month 22.5 mg were similar to that of the original daily subcutaneous injection and the monthly depot formulation. The most common side effect reported with Lupron Depot - 3 Month 22.5 mg was hot flashes (58.5 percent). Like other treatment options, it may also cause impotence. For many patients, Lupron Depot offers an alternative to surgical castration (orchiectomy). "Surgical castration is simply not an option many men want," said Dr. Crawford. "Lupron Depot - 3 Month 22.5 mg offers prostate cancer patients a very convenient, effective treatment without the negative psychological effects of surgical castration." "Lupron Depot - 3 Month 22.5 mg demonstrates TAP's continued commitment to finding more convenient treatments for prostate cancer patients," said TAP President Yasu Hasegawa. "Before we introduced Lupron Depot as a daily self-injection in 1985, advanced prostate cancer patients had limited treatment options. We've worked hard to expand those options and, today, with Lupron Depot - 3 Month 22.5 mg, patients need only one injection every three months." TAP also markets the drug Lupron Depot 3.75 mg for the hematologic improvement of anemia caused by uterine fibroid tumors (in combination with iron therapy) and for the management of endometriosis; Lupron Depot 7.5 mg is marketed by TAP as a palliative treatment for advanced prostate cancer; Lupron Depot - PED is marketed by TAP as a treatment for central precocious puberty. In addition, TAP markets the drug Lupron Depot (leuprolide acetate) Injection as a palliative treatment for advanced prostate cancer and as a treatment for central precocious puberty. TAP Holdings Inc., originally established as TAP Pharmaceuticals Inc. in 1977, is a joint venture of Abbott Laboratories, headquartered in Abbott Park, Ill., and Takeda Chemical Industries, Ltd. of Osaka, Japan. In 1995, TAP received marketing clearance from the FDA to market Prevacid(lansoprazole) Delayed-Release Capsules for short-term treatment (up to eight weeks) for healing and symptom relief of erosive esophagitis, active duodenal ulcers (up to four weeks) and for long-term treatment of hypersecretory conditions, including Zollinger Ellison syndrome.
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