FDA COMPLETES REVIEW OF CARDENE SR
FDA COMPLETES REVIEW OF CARDENE SR PALO ALTO, Calif., Jan. 23 /PRNewswire/ -- Syntex Corp.
(NYSE: SYN) said today that it has received an "approvable" letter from the United States Food and Drug Administration (FDA), indicating that the FDA has completed its review of Syntex's New Drug Application for approval to market a sustained release formulation of Cardene (nicardipine hydrochloride) for the treatment of hypertension.
Upon conclusion of final labeling discussions with the FDA, Syntex expects to be granted final approval to market Cardene SR. Syntex declined to speculate when final marketing approval may be granted. Syntex has marketed Cardene, a prescription calcium channel blocker taken in capsule form three times a day for the treatment of angina and hypertension, in the United States since March 1989. Cardene SR capsules, when approved for marketing, would be prescribed for use twice a day. Syntex is a multinational healthcare company that discovers, develops, manufactures and markets prescription medicines that treat serious human diseases. Syntex also develops, manufactures and markets animal pharmaceutical products and medical diagnostic systems. -0- 1/23/92 /CONTACT: Linda Thomas, 415-852-1321; or Jan R. Potts, 415-855-5052, both of Syntex Corp./ (SYN) CO: Syntex Corp. ST: California IN: MTC SU:
RM -- SJ007 -- 2877 01/23/92 14:13 EST
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|Date:||Jan 23, 1992|
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