Indevus Pharmaceuticalssaid its Supprelin-LA (histrelin acetate subcutaneous implant) 50mg has been approved by the FDA. Supprelin-LA is indicated for the treatment of central precocious puberty (CPP), the premature onset of puberty in children. Supprelin-LA is a once-yearly implant which utilizes patented hydron implant technology. The implant is inserted subcutaneously in the inner aspect of the upper arm and is specifically designed to provide a continuous release of approximately 65mcg/day over 12 months of the gonadotropin releasing hormone (GnRH) analog histrelin.
The FDA has approved Oscient Pharmaceuticals’ Factive (gemifloxacin mesylate) tablets for the five-day treatment of community-acquired pneumonia of mild to moderate severity (CAP). The approved supplemental New Drug Application (sNDA) was based on the results of the Company’s successful Phase III trial in 510 CAP patients comparing a five-day treatment and the originally approved seven-day treatment with Factive 320 mg once-daily. Oscient first launched Factive for the seven-day treatment of CAP and the five-day treatment of acute bacterial exacerbations of chronic bronchitis in the fall of 2004.
Bristol-Myers Squibb announced that the FDA has approved an update to the Orencia (abatacept) product labeling regarding the progression of structural joint damage in the treatment of rheumatoid arthritis (RA). The indication was strengthened from “slowing” to “inhibiting” the progression of structural damage in adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying, anti-rheumatic drugs such as methotrexate or tumor necrosis factor antagonists.
Japanese drugmaker Astellas and FibroGen reported that a US patient died of liver failure after taking their experimental anemia medicine known as FG-2216. FibroGen, based in San Francisco, reported the fatality to the FDA and will discuss the cause of death and future plans for the drug with the FDA, Astellas said in a statement on its Web site. Both companies are analyzing information on the case, which involved a 76-year-old patient taking 10 other medications, according to Astellas. FG-2216 is in Phase II testing and aims to help patients with chronic kidney disease and cancer increase levels of erythropoietin that stimulates production of red-blood cells. FG-2216, an oral treatment, is being developed as an alternative to Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit, injectables that have been linked to deadly side effects including strokes, and heart attacks in patients with chronic kidney failure.
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