FDAnews Drug Daily Bulletin

KING PHARMACEUTICALS REPORTS STATUS OF PEDIATRIC EXTENSION FOR ALTACE

March 27, 2006
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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 (ramipril) product.
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