Lanreotide acetate (Somatuline Depot Injection, Tercica) has been approved for the treatment of acromegaly, a rare and potentially life-threatening disease in adults. Abnormal secretion of growth hormone (GH) is commonly caused by a benign tumor in the pituitary gland.
The FDA has approved a supplemental biologics license application (sBLA) for alemtuzumab (Campath, Genzyme/ Bayer HealthCare) and has granted regular approval for single-agent therapy for use in B-cell chronic lymphocytic leukemia. This agent was initially approved in 2001 under accelerated regulations.
The FDA has approved raloxifene HCl (Evista drags, Eli Lilly) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. As a selective estrogen receptor modulator (SERM), generic raloxifene may act by blocking estrogen receptors in the breast.
In 1997, the FDA approved (buy) raloxifene for preventing osteoporosis in postmenopausal women; in 1999, it was approved for treating osteoporosis in post-menopausal women.
The FDA has approved a supplemen tal biologics license application (sBLA) for alemtuzumab (Campath, Genzyme/ Bayer HealthCare) and has granted regular approval for single-agent therapy for use in B-cell chronic lymphocytic leukemia. This agent was initially approved in 2001 under accelerated regulations.
The FDA has approved a five-day, once-daily IV and oral 750-mg regimen of levofloxacin (generic Levaquin, Ortho-McNeil, PriCara) for patients with complicated urinary tract infections (UTIs) and acute pyelonephritis (kidney infection).
The FDA has approved a once-daily tablet combining amlodipine (Norvasc), a calcium-channel blocker, and olmesartan medoxomil (Benicar drags), an angiotensin-receptor blocker, for the treatment of hypertension. In clinical trials, Azor produced significant mean reductions in systolic and diastolic blood pressure. When compared with generic amlodipine 10 mg alone, Azor 10/40 mg resulted in a 53% greater reduction in systolic blood pressure.
Lanreotide acetate (Somatuline Depot Injection, Tercica) has been approved for the treatment of acromegaly, a rare and potentially life-threatening disease in adults. Abnormal secretion of growth hormone (GH) is commonly caused by a benign tumor in the pituitary gland.