Drug Topics - November 10, 2008 - (Page 14)

Clinical FDA CERTIFICATION RX CARE Julio Fernandez, PharmD Barr gains approval for generic version of Razadyne Barr Pharmaceuticals Inc., recently announced that its subsidiary, Barr Laboratories Inc., received ﬁnal approval from the U.S. Food and Drug Administration for a generic version of Razadyne ER, Ortho McNeil Janssen’s galantamine hydrobromide extended release capsules. Galantamine, a tertiary alkaloid, is a competitive and reversible acetylcholinesterase inhibitor. B arr also announced it is the ﬁrst company to ﬁle an While the precise mechanism of galantamine’s action Abbreviated New Drug Application (ANDA) with is unknown, it is postulated that it exerts its therapeuthe FDA containing a Paragraph IV certiﬁcation for a ge- tic effect by enhancing cholinergic function. If this is neric version of Razadyne ER capsules, and therefore it is the case, galantamine’s effect may lessen as the disease entitled to 180 days of marketing exclusivity, as provided progresses and fewer cholinergic neurons remain funcfor under the Hatch-Waxman Act. Barr ﬁled its ANDA tionally intact. Cluxton said that as with all agents in with the FDA containing a Paragraph IV certiﬁcation for this class, galantamine has no impact on the underlying the 8 mg capsule strength of Razadyne ER disease and effects only modest and temon March 1, 2006, and amended its ANDA porary improvement in cognition. 5.2 million on March 10, 2006, to include the 16 mg Galantamine extended-release (ER) and 24 mg capsule strengths. is indicated for the treatment of mild to Americans “Assuming the price is less than any moderate dementia of the Alzheimer’s will have of the branded drugs in this class, generic type. The efficacy of galantamine’s ER Alzheimer’s Razadyne ER will be a more cost-effective disease in option for most patients who respond to 2008. cholinesterase inhibitors. Having a less expensive cholinesterase inhibitor available likely will make it the ﬁrst-choice agent in the class for patients just being started on cognitive therapy, since there is no way to tell which drug in this class the patient is most likely to respond to,” Robert J. Cluxton Jr., PharmD, MBA, CGP, said. Cluxton is Professor of Pharmacy Practice and Family Medicine at the James L. Winkle College of Pharmacy, University of Cincinnati. Alzheimer’s disease is the most common cause of dementia. The Alzheimer’s Association estimated that 5.2 million Americans will have Alzheimer’s disease in 2008. In 2000, there were an estimated 411,000 new cases of Alzheimer’s disease. That number is expected to increase to 454,000 new cases a year by 2010 and to 615,000 new cases a year by 2030. Treating Alzheimer’s disease can be challenging, as the pathology of the disease is not fully understood. The FDA-approved drugs may slow the progression of Alzheimer’s disease for a few months or even a few years. They may help some patients perform activities of daily living and decrease behavioral symptoms such as delusions and agitation. They may even improve memory and speaking skills. But they are not a cure. 14 DRUG TOPICS N OV. 10, 2008 W W W.D R U GTO P I C S .C O M GETTY IMAGES / PHOTOALTO / DIMIER http://WWW.DRUGTOPICS.COM

Table of Contents Feed for the Digital Edition of Drug Topics - November 10, 2008

Drug Topics - November 10, 2008 Contents Up Front Up Front in Depth Letters Rx Care Government Community Practice First Responders Clinical Practice Self-Care FDA Safety Page Weighing the Complications of Obesity New Products Viewpoint

Drug Topics - November 10, 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.