Alkermes submits VIVITROL sNDA for opioid dependence Alkermes.

The most common adverse occasions experienced by sufferers receiving VIVITROL through the study were nasopharyngitis and insomnia.. Alkermes submits VIVITROL sNDA for opioid dependence Alkermes, Inc.S. Food and Drug Administration for acceptance as cure for opioid dependence. The business requested a priority review for its sNDA and if granted by the FDA, it could mean a six month critique timeline. The sNDA is founded on the positive results from a recently available phase 3 research assessing the efficacy and protection of VIVITROL for opioid dependence. VIVITROL is an opioid antagonist administered by intramuscular injection and is approved in the U once-monthly.S.

‘In the fourth one fourth of 2007 we finalised a few agreements that are evidence to our growth strategy – amongst others, the acquisition of Bradley Pharmaceuticals was closed in early 2008 successfully, as were agreements with Sepracor and Baxter International in the United States. Our markets in Latin America and Russia/CIS along with in Southern and Eastern European countries continued to develop at very satisfactory prices. And our substantial increase in adjusted EBITDA demonstrates our capability to focus on high-efficiency performance’, he continued. About Nycomed Nycomed is definitely a possessed pharmaceutical company that provides medicines for hospitals privately, professionals and general practitioners, and also over-the-counter medicines in selected markets.‘In the fourth one fourth of 2007 we finalised a few agreements that are evidence to our growth strategy – amongst others, the acquisition of Bradley Pharmaceuticals was closed in early 2008 successfully, as were agreements with Sepracor and Baxter International in the United States. Our markets in Latin America and Russia/CIS along with in Southern and Eastern European countries continued to develop at very satisfactory prices. And our substantial increase in adjusted EBITDA demonstrates our capability to focus on high-efficiency performance’, he continued. About Nycomed Nycomed is definitely a possessed pharmaceutical company that provides medicines for hospitals privately, professionals and general practitioners, and also over-the-counter medicines in selected markets.