On
In accordance with a special protocol assessment agreement between the FDA and CV Therapeutics, the Company believes that data from the MERLIN TIMI-36 study could support expansion of the existing Ranexa indication to first line angina.
Following submission of the initial sNDA, the FDA initiated a separate sNDA review by the Division of Cardiovascular and Renal Products to evaluate the approval of potential anti-arrhythmic claims and a separate new drug application review by the Division of Metabolism and Endocrinology Products to evaluate the approval of potential HbA1c reduction claims in patients with coronary artery disease.
Ranexa is currently indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in
CV Therapeutics' approved products in
Except for the historical information contained herein, the matters set
forth in this press release, including statements as to research and
development and commercialization of products, are forward-looking statements
within the meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are subject to
risks and uncertainties that may cause actual results to differ materially,
including operating losses and fluctuations in operating results; capital
requirements; regulatory review and approval of our products; special protocol
assessment agreement; the conduct and timing of clinical trials;
commercialization of products; market acceptance of products; product
labeling; concentrated customer base; reliance on strategic partnerships and
collaborations; uncertainties in drug development; uncertainties regarding
intellectual property and other risks detailed from time to time in CV
Therapeutics' SEC reports, including its Quarterly Report on Form 10-Q for the
quarter ended
SOURCE CV Therapeutics, Inc.