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FDA panel rejects bid to broaden beta blocker indication.

Chemical Business Newsbase

| January 12, 2010 | COPYRIGHT 2000 Elsevier Engineering Information, Inc. (Hide copyright information)Copyright

A cardiovascular advisory panel has unanimously agreed that the FDA should not expand the indications for the beta blocker nebivolol (Bystolic) to include treatment of heart failure in older patients. The Cardiovascular and Renal Drugs Advisory Committee voted 8-0 against using nebivolol, made by Forest Laboratories (Forest), for 'any heart failure population to reduce mortality and cardiovascular hospitalization'. FDA's report stated that there was no convincing evidence to support expanding indications for the beta blocker. In 2007 the FDA approved the drug for treatment of hypertension. For comparison, the reviewers referenced the two beta blockers approved by the FDA for treatment …

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