The FDA approved Eli Lilly’s osteoporosis drug Evista to reduce breast cancer risk in some postmenopausal women. Specifically, the FDA approved Evista to lower the risk of invasive breast cancer (the most common form of breast cancer) in two groups of women: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer, Evista is only the second drug approved to reduce breast cancer risk (tamoxifen was the first). In the US, breast cancer is the No. 2 cause of women’s cancer deaths (lung cancer is first). Breast cancer accounts for 26% of all cancers among US women.
Mylan Laboratories has received tentative approval from the FDA for its Abbreviated New Drug Application for topiramate capsules, 15 mg and 25 mg. Topiramate capsules are the generic version of Ortho McNeil Pharmaceuticals’ Topamax sprinkle capsules which had US sales of approximately $46 million for the 12 months ending June 30, 2007.
The FDA has approved a high-dose regimen of Johnson & Johnson’s antibiotic Levaquin to treat complicated urinary tract and kidney infections.
