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SYNTEX STARTS NDA FILE FOR NICARDIPINE IN ANGINE

Executive Summary

SYNTEX STARTS NDA FILE FOR NICARDIPINE IN ANGINE with the June submission of the chemistry and pharmacy sections of the NDA for the calcium channel blocker. Syntex Chairman and CEO Albert Bowers told New York security analysts on June 12 that the company expects to file the remainder of the application this summer. An NDA for the hypertension indication for the drug, licensed from Yamanouchi, is expected to be filed "early in calendar year 1986," he added. Under the NDA rewrite regulations, companies can submit the chemistry and pharmacy section of a NDA 90 to 120 days in advance of the remainder of the application. FDA review of the information is supposed to begin immediately with the first filing. Nicardipine is the second drug for which Syntex has used the expedited filing procedure. Syntex' NDA submission for Gardrin (enprostil), for treatment of duodenal ulcer, was begun in April and is expected to be completed in July, the company said. At present, Knoll's Isoptin (verapamil), co-marketed by Searle, has a head start on the other calcium channel blockers toward receiving a hypertension claim in the U.S. FDA's Cardio-Renal Advisory Cmte. recommended the drug for approval in hypertension on April 11 ("The Pink Sheet" April 15, p. 10). Rizer (Procardia) and Marion (Cardizen) have both indicated they will file for hypertension in 1985. Bayer's U.S. subsidiary, Miles, may be able to market nifedipine in the U.S. in 1986 when the clock on Pfizer's exclusive license to market the drug is expected to run out. Outside of the U.S., Bayer sells the drug under the name, Adalat. Bayer has reportedly filed an NDA in the U.S. for its second generation calcium channel blocker nitrendipine in hypertension. Nitrendipine was approved for marketing last February in West Germany, where it was launched in April as Bayotensin for hypertension. Nitrendipine is in the registration process in several other countries. Recommended dosage of the drug in Germany, is one 20 mg tablet daily.
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