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Executive Summary

DuPont Merck received FDA approval for Cardene I.V. (nicardipine) on Jan. 30. The approved label indicates Cardene I.V. for "the short-term treatment of hypertension when oral therapy is not feasible or not desirable." The labeling specifies that the drug is not for "prolonged control of blood pressure." The final approval for Cardene I.V. comes one month after the product reached "approvable" status on Dec. 31. DuPont Merck filed for an NDA on June 19, 1987 and resubmitted the application on July 23, 1991. FDA's Cardio-Renal Drugs Advisory Committee recommended that the drug be approved for second-line therapy of hypertension at its June 15, 1990 meeting ("The Pink Sheet" June 18, 1990, T&G-3). Labeling states that Cardene I.V.'s "dosage must be individualized depending upon the severity of hypertension and the reponse of the patient during dosing." Patients suffering from hypertension "should be transferred to oral medication as soon as their clinical condition permits," labeling adds. The labeling includes data collected from two multicenter, double-blind, placebo-controlled clinical trials involving 244 patients. "Adverse experiences were generally not serious and most were expected consequences of vasodilation. Adverse experiences occasionally required dosage adjustment," labeling states. Among the 244 patients, 12% discontinued therapy, "mainly due to hypotension, headache and tachycardia." DuPont Merck expects to launch Cardene I.V. in the second quarter of 1992. The company sublicenses nicardipine from Syntex, which in turn licenses rights to Cardene from the Japanese pharmaceutical firm Yamanouchi. Syntex markets the oral version of Cardene. Another cardiovascular drug, Abbott's Nitropress (sodium nitroprusside) injectable, was approved on Dec. 31 for a new indication, treatment of acute congestive heart failure. Nitropress is also used for immediate reduction of blood pressure for patients in hypertensive crisis, and for controlled hypotension to reduce bleeding during surgery. Boehringer Ingelheim's Alupent (metroproterenol) inhalation solution received approval on Nov. 14 for management of acute asthma attacks in children six years of age and older. Alupent is the first beta adrenergic bronchodilator nebulized solution to be indicated for pediatric use, the company said. Boehringer estimates that 7.5% of children between the ages of six and 11 in the U.S. suffer from asthma. The firm recently filed an application for a new nasal spray formulation of its anticholinergic bronchodilator Atrovent (ipratropium bromide).

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