Norethindrone acetate/ethinyl estradiol tablets approved Oct. 15 in a 1/5 dose for the treatment of moderate to severe vasomotor symptoms associated with menopause and for prevention of osteoporosis in women with an intact uterus. FDA rejected an application for the higher 1/10 dose of Femhrt, noting that "optimally, drugs used to prevent osteoporosis are administered at the lowest effective dose." Warner-Lambert plans to launch the product by the end of the year
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth