FDA Issues Complete Response Letter for CorVue[TM].BRISTOL, Tenn. -- King Pharmaceuticals, Inc. (NYSE NYSE See: New York Stock Exchange : KG) announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) issued a complete response letter regarding the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for CorVue[TM] (binodenoson) for injection. CorVue[TM] is a cardiac pharmacologic stress agent for use as an adjunct in SPECT SPECT single-photon emission computed tomography. SPECT abbr. single photon emission computed tomography SPECT, n See single photon emission computer tomography. (single-photon-emission computed tomographic) cardiac imaging intended for use in patients with or at risk for coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. (CAD) who are unable to perform a cardiac exercise stress test. King is currently evaluating the FDA's complete response letter and expects to respond to the Agency's questions as quickly as possible. About Coronary Artery Disease Coronary artery disease is a condition in which plaque builds up inside the coronary arteries Coronary arteries The two main arteries that provide blood to the heart. The coronary arteries surround the heart like a crown, coming out of the aorta, arching down over the top of the heart, and dividing into two branches. , thereby narrowing or blocking the arteries and reducing blood flow to the heart. CAD is one of the most common forms of cardiovascular disease and is the leading cause of death globally. In the United States, it is estimated that CAD affects 16 million adults and kills more that 450,000 annually - about one in every five deaths. About CorVue[TM] CorVue[TM], a selective adenosine adenosine /aden·o·sine/ (ah-den´o-sen) a purine nucleoside consisting of adenine and ribose; a component of RNA. It is also a cardiac depressant and vasodilator used as an antiarrhythmic and as an adjunct in myocardial perfusion imaging A2A A2A Access to Archives (UK) A2A Application to Application A2A Air-To-Air (weapon) A2A Administration-to-Administration A2A Any to Any receptor agonist, is being developed as an alternative to exercise prior to cardiac perfusion imaging for the diagnosis of coronary artery disease. CorVue[TM] is designed to minimize side effects such as dyspnea dyspnea /dysp·nea/ (disp-ne´ah) labored or difficult breathing.dyspne´ic paroxysmal nocturnal dyspnea , flushing, heart block and chest pain. For ease of administration, CorVue[TM] is being developed for dosing as a single IV injection. CorVue[TM] has a fast onset while providing a sufficient duration of coronary blood vessel dilation dilation /di·la·tion/ (di-la´shun) 1. the act of dilating or stretching. 2. dilatation. di·la·tion n. 1. for flexibility in diagnostic imaging. About King Pharmaceuticals, Inc. King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company's focus in specialty-driven markets, particularly the neuroscience and hospital markets. King's wholly-owned subsidiary, Alpharma, Inc., is also a leader in the development, registration, manufacturing and marketing of pharmaceutical products for food producing animals. About Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 (the "Act"). When used in this press release, the words "estimate," "project," "anticipate," "expect," "intend," "believe," and similar expressions are intended to identify forward-looking statements. King Pharmaceuticals, Inc. disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risk factors include, but are not limited to, our ability to gain FDA approval of the CorVue[TM] NDA, and the timing of any such approval; King's ability to gain FDA approval of product labeling for the proposed indication for CorVue[TM]; and the market acceptance and sales potential for CorVue[TM]. You are encouraged to review these and other risks and uncertainties detailed in King's Annual Report on Form 10-K for the year ended December 31, 2008, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, each of which is on file with the U.S. Securities and Exchange Commission. |
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