Tuesday 11 December, 2007

Valsartan got Paediatric exclusivity in USA

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

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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