FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa(R)
December 07 2007 - 7:00AM
PR Newswire (US)
PALO ALTO, Calif., Dec. 7 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the U.S. Food
and Drug Administration (FDA) has notified the Company that it will
evaluate the approval of potential anti-arrhythmic claims for
Ranexa(R) (ranolazine extended-release tablets) as part of its
ongoing review of the Company's supplemental new drug application
(sNDA). This follows the FDA's acceptance of an sNDA seeking
expansion to the approved product labeling for Ranexa to include a
first line angina indication and a significant reduction in
cautionary language as well as a separate NDA for a potential
labeling change to add reduction of hemoglobin A1c (HbA1c) in
coronary artery disease patients with diabetes. The two sNDAs are
being reviewed by the FDA Division of Cardiovascular and Renal
Products and the NDA is being reviewed by the FDA Division of
Metabolism and Endocrinology Products. The Prescription Drug User
Fee Act (PDUFA) action date for the sNDAs and the NDA is July 27,
2008. The FDA has requested, and CV Therapeutics has paid three
separate user fees to support the review of both sNDAs and the NDA.
"We anticipate receiving approval for first line angina use, which
would significantly expand the patient population eligible to
receive Ranexa, and we are very pleased that the FDA also is now
evaluating separate potential anti- arrhythmic and HbA1c reduction
claims for Ranexa on the same timeline," said Louis G. Lange, CV
Therapeutics chairman and chief executive officer. In September
2007, data published in Circulation and presented at the European
Society of Cardiology Congress 2007 in Vienna, Austria showed that
Ranexa reduced ventricular arrhythmias in patients receiving Ranexa
compared to placebo in the MERLIN TIMI-36 study. Patients receiving
Ranexa had a 37 percent reduction in their relative risk of
ventricular tachycardia lasting eight beats or more (p
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