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Executive Summary

American Critical Care will market Syntex' I.V. nicardipine and Merck's prodrug of diphenylhydantoin under separate licensing agreements announced Aug. 5. American Hospital Supply Corp.'s hospital drug marketing division said in a press release that "under agreement with Syntex U.S.A., American Critical Care will develop and market an injectable form of nicardipine, a calcium channel blocker used to treat hypertension, congestive heart failure and angina." American Critical Care added that it has already begun clinical development of nicardipine and "will provide Syntex with data for the NDA filing." In June, Syntex began filing its NDA for oral nicardipine with the submission of the chemistry and pharmacy sections of the application under FDA's new expedited format, Syntex Chairman Albert Bowers, PhD, reported at a recent presentation to analysts. Under the NDA rewrite regulations, companies can now submit the chemistry and pharmacy section of an NDA 90-120 days in advance of the remainder of the application. Bowers told the analysts that the company expected to have the remainder of the NDA submission completed by the end of the summer. Nicardipine is licensed from Yamanouchi. Nicardipine I.V. would be the second important injectable cardiovascular drug in American Critical Care's pipeline. The firm's internally developed injectable beta blocker Brevibloc (esmolol) is currently pending approval at FDA following submission of an NDA in late 1984. American Critical Care noted that Brevibloc has been classifed 1-A (new chemical entity representing an important therapeutic advancel by FDA. When approved, Brevibloc will be the "only titratable ultra-short-acting beta blocker available" for the acute care setting, the firm said. The AHSC subsidiary's agreement with Merck covers both development and marketing of the prodrug of diphenylhydantoin. "The prodrug is expected to improve the solubility and stability of injectable diphenylhydantoin, used for control of epilepsy," the release points out. Current marketers of phenytoin I.V. include Parke-Davis (Dilantin) and Elkins-Sinn. American Critical Care added that it is "also expanding its efforts to bring a broad line of generic drugs to hospitals to take advantage of the high growth in the generic drug marketplace."

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