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Executive Summary

MERCK's TONOCARD TWICE DAILY ANTI-ARRHYTHMIC APPROVAL BY FDA NOV. 9 for the "suppression of symptomatic ventricular arrhythmias" makes the MS&D drug the first of the new generation of anti-arrhythmics to clear FDA. Tonocard (tocainide) will be launched the week of Nov. 26. The price to whslrs. and retail pharmacies is $33.61 for 400 mg 100s and $42.85 for 600 mg 100s. The drug is a product of Merck's research and development agreement with Astra. The anti-arrhythmic was classified by FDA as a 1B drug, signifying a new chemical entity with modest therapeutic gain. Tonocard was approved approximately 2-1/2 years after Merck submitted an NDA in May 1982; Astra filed an NDA for the drug in June 1981. The agency's cardio-renal drugs advisory cmte. recommended approval of the drug at a meeting last March. At that time, cmte. reviewer Raymond Woosley, MD/PhD, University of Indiana, noted that central nervous system reactions, tremors and dizziness are generally better tolerated with Tocainide than with other anti-arrhythmic agents. Tonocard is the first drug developed under Merck's licensing joint venture with Astra to clear FDA. Other drugs included in the venture, formed in July 1982, are Pulmicort (budesonide), a topical steroid, anti-inflammatory/anti-allergy/anti-asthma agent, and omeprazole, an anti-ulcer agent in Phase III testing. Zelmid (zimeldine) was also being developed under the agreement with Astra, but Merck withdrew the NDA in October 1983 after Astra removed the drug from European markets due to concerns of adverse effects. Merck's promotional campaign for Tonocard may highlight its similarity to lidocaine. In a photograph in Merck's 1983 annual report, the promo slogan "Like Lidocaine: But It's Oral" is pictured in a mock-up ad on a desktop ("The Pink Sheet" March 19, "In Brief"). The firm's annual report also notes that the drug will be manufactured for the U.S. market in Puerto Rico, as will the Merck drug enalapril. An NDA for enalapril is still pending at FDA. Enalapril was unanimously recommended for approval for all degrees of hypertension and for the management of congestive heart failure by FDA's advisory cmte. in June.

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