The U.S. Food and Drug Administration has approved Diovan (valsartan) for use on children between the ages of six and sixteen following a priority review. Diovan is an angiotensin receptor blocker (ARB). The drug has already been previously approved for use by adults suffering from high blood pressure.of children and adolescents suffer from high blood pressure. It is believe that nearly 5% Novartis Pharmaceuticals, the manufacturer of Diovan, claims that studies showed no difference in adverse affects on children than were previously reported for adults. Those side effects can include: headache and dizziness or more seriously hypotension and kidney problems.
"Novartis believes it is important to provide physicians with treatment options such as Diovan which are effective in treating high blood pressure in this vulnerable population of children and adolescents," said John Orloff, MD, Senior Vice President, Medical and Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation.
The new expiry of product patent in USA is september 21, 2012
Tuesday, 11 December 2007
Valsartan got Paediatric exclusivity in USA
Posted by ADKS at 5:12 pm
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