FDA approves fifth H1N1 vaccine
ROCKVILLE, Md. The Food and Drug Administration on Monday announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus, this one manufactured by ID Biomedical of Quebec, Canada, which is owned by GlaxoSmithKline.
As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept. 15, ID Biomedical Corp. will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.
ID Biomedical’s H1N1 monovalent vaccine will be produced in multidose vials, in a formulation that contains thimerosal.
FDA approves Par’s chronic pain drug
WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a generic version of a chronic pain drug.
Par Pharmaceuticals announced Monday the approval of tramadol extended-release tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Johnson & Johnson’s Ultram ER, which has sales of $156 million per year, according to IMS Health. Ultram ER is used to treat chronic pain in adults who require around-the-clock treatment.
The U.S. District Court for the District of Delaware ruled in August that Par could market a generic version of the drug. Par plans to begin shipping the drug immediately.
Addrenex acquired by Sciele Pharma
DURHAM, N.C. The U.S. subsidiary of a Japanese drug maker has acquired a company that develops drugs for medical conditions related to the body’s adrenergic system.
Addrenex Pharmaceuticals announced Monday its acquisition by Sciele Pharma, the Atlanta-based subsidiary of Shionogi & Co., one of Japan’s largest drug companies, for $29 million. Sciele already held stock in Addrenex and licensed drugs from the Durham, N.C.-based company.
“Sciele has been a valuable partner and catalyst for the success of Addrenex,” Addrenex CEO Moise Khayrallah said in a statement. “Our initial business plan called for bringing innovative drugs to market and enabling our investors to achieve a positive return.”
Sciele had licensed Addrenex’s attention-deficit hyperactivity disorder drug Clonicel (clonidine) and the hypertention drug Jenloga XR (once-daily clonidine). Addrenex has four drugs in clinical trials and more than 400 possible drug candidates.