January 06, 2006
Product News from the 01/06/06 News Brief
The FDA approved Celgene’s Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with abnormalities. According to a company news release, distribution of lenalidomide is expected to begin in early 2006. Astellas Pharma US said the FDA approved Vaprisol (conivaptan hydrochloride injection), an arginine vasopressin antagonist for the intravenous treatment of euvolemic hyponatremia in hospitalized patients. The FDA approved Bristol-Myers Squibb’s Orencia (abatacept), the first selective modulator of a co-stimulatory signal required for full T-cell activation, for the treatment of rheumatoid arthritis. Data published in the January issue of Mayo Clinic Proceedings showed that Requip (ropinirole HCl) tablets significantly improved RLS symptoms. The study, entitled “TREAT RLS US (Therapy with Ropinirole, Efficacy and Tolerability in Restless Legs Syndrome),” is the largest US study to date of the treatment of RLS. Novartis breast cancer drug Femara (letrozole) won a new indication for preventing relapse after surgery in women past menopause who have early breast cancer.The drug is already approved for use in treating advanced breast cancer and for use after five years of standard treatment with an older cancer drug, tamoxifen.