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Article: King Pharmaceuticals Reports Status of Pediatric Extension for Altace(R).
- Article from:
- PR Newswire
- Article date:
- March 24, 2006
CopyrightCOPYRIGHT 2006 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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BRISTOL, Tenn., March 24 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. today reported that, in recent communications with the U.S. Food and Drug Administration ("FDA"), the Company has been informed that the data from its completed TOPHAT (Treatment of Pediatric Hypertension with Altace Trial) clinical trial submitted in support of its supplemental New Drug Application ("sNDA") are insufficient, and the Company believes that, subject to additional discussions with the FDA, 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 Company's Altace(R) (ramipril) product. In light ...