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news.The FDA has informed King Pharmaceuticals that data from its clinical trial evaluating hypertension drug Altace in children is insufficient to gain a six month patent extension.
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The company said that it is yet to have additional discussions with the FDA but that it may be necessary to conduct a second clinical trial in order to receive an additional six months of exclusivity beyond patent expiry for the product.
Should such an additional clinical trial be necessary, and provided that the study is completed and reported to the FDA by the third quarter of 2008 and that the results meet the FDA’s requirements, the company believes it can satisfy the applicable regulations and obtain an additional six months of market exclusivity.
The trial of the drug in children was initiated in response to the FDA’s written request for additional information regarding Altace that may produce health benefits in pediatric populations.