COR Therapeutics, Inc. Submits Amendment to NDA For Integrilin (Eptifibatide).SOUTH SAN FRANCISCO--(BUSINESS WIRE)--Oct. 1, 1997--COR Therapeutics, Inc. (Nasdaq: CORR CORR Used on the consolidated tape to indicate a correction in a reported transaction : CORR.LAST.GY 50 WAS 51. ) announced today that it has submitted an amendment to its original 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 ) to the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) seeking marketing approval of INTEGRILIN(TM) (eptifibatide). The amendment addresses issues raised in the FDA's action letter of March 1997, and includes clinical data from the PURSUIT trial, which studied the effect of INTEGRILIN(TM) in the treatment of patients with unstable angina and non-Q-wave myocardial infarction. PURSUIT is the largest clinical study ever conducted in this patient population. COR and Schering-Plough Corporation are worldwide partners for INTEGRILIN(TM). COR Therapeutics, Inc. is dedicated to the discovery, development and commercialization of novel pharmaceutical products for the treatment and prevention of severe cardiovascular diseases. COR has complementary product research and development programs that seek to address critical needs in severe cardiovascular care, including unstable angina, acute myocardial infarction acute myocardial infarction (  ·kyōōtˑ mī·ō·karˑ·dē· , deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. and restenosis. -0- In addition to the historical information contained herein, this press release contains forward-looking statements that are subject to risks and uncertainties that may cause the Company's actual results to differ materially. A full discussion of the Company's operations and financial condition, and specific factors that could cause the Company's actual performance to differ from current expectations, are discussed in the Company's SEC reports, including, but not limited to, the Company's Report on Form 10-Q for the quarter ended June 30, 1997 and Report on Form 10-K for the year ended December 31, 1996. CONTACT: COR Therapeutics, Inc., South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. Laura A. Brege Jacquelyn A. Jeffries 650/244-6893 or Burns McClellan, Inc., New York Lisa Burns Jonathan M. Nugent 212/213-0006 |
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