www.fdanews.com/articles/85550-king-pharmaceuticals-reports-status-of-pediatric-extension-for-altace
KING PHARMACEUTICALS REPORTS STATUS OF PEDIATRIC EXTENSION FOR ALTACE
March 24, 2006
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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