March 27, 2007
Product news from the 03/27/07 news brief
The FDA has approved UCB's anti-epileptic drug Keppra (levetiracetam), as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Astellas Pharma US said the FDA has approved Vaprisol (conivaptan hydrochloride injection), an arginine vasopressin (AVP) receptor antagonist, for the intravenous treatment of hypervolemic hyponatremia in hospitalized patients. Vaprisol is the first drug specifically indicated for the treatment of both euvolemic and hypervolemic hyponatremia, potentially life-threatening conditions that occur when the body's blood sodium level falls significantly below normal. Vaprisol was approved by the FDA as a treatment for euvolemic hyponatremia in December 2005, and has been marketed by Astellas since April 2006. Sanofi-Aventis said the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet June 13 to discuss the drugmaker’s CB1 receptor antagonist Acomplia (rimonabant) in obesity patients.