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Executive Summary

Research by Upjohn and Symphar on anti-atherosclerotic compounds has produced at least two agents in a potentially new class of cardiovascular agents for the U.S. market. The two anti-atherosclerotic compounds, Upjohn's timefurone and Symphar's Clenicor (mifobate), are included in a compilation of new generic drug name listings from the just-released 1985 edition of the USAN and USP Dictionary of Drug Names. The two compounds are treated as a new class of compounds by the dictionary and are distinguished from the lipid lowering class of agents such as Lopid (gemfibrozil), Questran (cholestyramine), and Colestid (colestipol). Overall, 63 human pharmaceuticals -- from a total of 68 new chemical compounds -- are listed in the U.S. Pharmacopeial (USP) Convention's dictionary of generic drug names for the first time in the 1985 edition. First-time entries also include two veterinary compounds, suture material and contact lens material listings, and the generic name of the tablet excipient in Nelson Research's Azone controlled release technology, laurocapram. Lilly, with six new compounds (including one veterinary agent), leads all companies with newly listed pharmaceutical compounds in the USP dictionary for the second year in a row. Among the human compounds listed are the anti-arrhythmic indecainide, in early clinicals; the antihypertensive, pinacidil; and the anti-depressant tomoxetine. Lilly said it is not actively pursuing approval for the gout suppressant amflutizole and the anticancer agent vinepidine. Following Lilly in the number of new listings in the 1985 edition of the USP dictionary are Merck, Syntex, and SmithKline Beckman, with four new listings each, and Upjohn, Searle, Bristol-Myers, Stuart and Parke-Davis, each with three new entries. Among drug classes, cardiovascular agents for outnumbered other therapeutic categories with 16 newly listed compounds, followed by antibacterials (seven new listings), gastrointestinals (six listings), antidepressants and antineoplastic agents (four each), and topical steroid formulations (three listings). Representatives of heralded new drug classes appearing among the new entries in the 1985 USP dictionary include the leutinizing hormone/releasing hormone (LHRH) agonists, lutrelin (Wyeth) and nafarelin (Syntex); prostaglandin antiulcer agents, enprostil (Syntex) and enisoprost (Searle); angiotensin converting enzyme (ACE) inhibitor antihypertensives, indolapril (Parke-Davis) and lisinopril (Merck); and calcium channel blockers, mioflazine (Janssen) and fostedil (Abbott). The two LHRH agonists are progressing through clinicals, both Syntex and Wyeth have indicated. The therapeutic class is expected to be useful as a contraceptive in both males and females, as well as an effective agent in the treatment of some cancers. Syntex has also indicated that its antiulcer agent enprostil is now in Phase III clinicals. While Searle's enisoprost is in early clinical evaluation, the firm was the first to file an NDA for a prostaglandin anti-ulcer agent, when it submitted its data for Cytotec (misoprostil) during the spring ("The Pink Sheet" July 19, T&G-1). The Parke-Davis ACE inhibitor indolapril is currently in Phase II clinical trials. The two other Parke-Davis compounds listed for the first time in the USP dictionary include the anticancer agent dezaguanine and the antibacterial enoxacin, which is in early clinicals. The USAN indicated that enoxacin was developed by the Japanese firm, Dainippon. The preface to the USP dictionary explains that a USAN (U.S. adopted name) listed "originates from a firm or an individual who has developed a substance of potential therapeutic utility to the point there there is a distinct possibility of its being marketed in the U.S." The preface adds that "the process of selecting a USAN should be initiated preferably during the period of investigation when the substance is under clinical study in human and animal subjects, so that the adoption of the USAN will be complete by the time the relevant NDA is filed." However, initial listing in the USAN does not necessarily mean that a drug is in the pre-NDA stage. For example, SmithKline's Monocid (cefonicid) and Glaxo's Zinacef (cefuroxime) have both been introduced to the U.S. market within the last 12 months and trimethoprim in other chemical forms has been marketed for years and is now off patent. The dictionary is available from USP for $49.95 (prepaid). Copies may be obtained by writing USP at 12601 Twinbrook Parkway, P.O. Box 2248, Rockville, Md. 20852. NEW U.S. ADOPTED NAMES (USAN) INCLUDED IN THE 1985 EDITION OF USAN AND THE USP DICTIONARY OF DRUG NAMES Aceglutamide aluminum (anti-ulcerative), Glumal, Kyowa Hakko Kogyo Acetohydroxamic acid (enzyme inhibitor-urease), Lithostat, Mission Pharmacal Amflutizole (gout suppressant), Lilly Aptazapine maleate (antidepressant), Ciba-Geigy Avridine (antiviral), Pfizer Carbetimer (antineoplastic), Monsanto Cefetamet (veterinary antibacterial), Lilly Cefonicid monosodium (antibacterial), Monocid, SK&F Cefotetan (antibacterial), Apacef, Stuart Cefotetan disodium (antibacterial), Stuart Cefuroxime (antibacterial), Zinacef, Glaxo Cefuroxime axetil (antibacterial), Glaxo Ciglitazone (antidiabetic), Upjohn, Takeda Cilastatin sodium (enzyme inhibitor), Merck Cisapride (peristaltic stimulant), Janssen Clobetasol propionate (anti-inflammatory), Removate, Glaxo Clobetasone butyrate (anti-inflammatory), Glaxo Clonidine (antihypertensive), Catapres TTS, Boehringer-Ingelheim Dazopride fumarate (peristaltic stimulant), Robins Dezaguanine (antineoplastic), Parke-Davis Dezaguanine mesylate (antineoplastic), Parke-Davis Dicirenone (hypotensive; aldosterone antagonist), Searle Dilevalol HCl (antihypertensive; beta blocker), Schering-Plough Dribendazole (anthelmintic), SK&F Enalaprilat (antihypertensive), Merck Enisoprost (anti-ulcerative), Searle Enoxacin (antibacterial), Parke-Davis, Dainippon Enprostil (antisecretory; anti-ulcer), Syntex Esmolol HCl (beta blocker), American Critical Care Fenoldopam mesylate (antihypertensive; dopamine agonist), SK&F Fezolamine fumarate (antidepressant), Sterling Fluzinamide (anticonvulsant), Robins Fostedil (vasodilator, Calcium channel blocker), Abbott, Kanebo Indecainide HCl (cardiac depressant; anti-arrhythmic), Lilly Indolapril HCl (antihypertensive), Parke-Davis Iotrol (radiopaque medium), Schering A.G. Iproplatin (antineoplastic), Bristol-Myers Laurocapram (pharmaceutic aid; tablet excipient), Azone, Nelson Research Lisinopril (antihypertensive), Merck Lofemizole HCl (anti-inflammatory; analgesic; anti-pyretic), Farmatis S.R.L. Lutrelin acetate (LHRH agonist), Wyeth Mifobate (anti-atherosclerotic), Clenicor, Symphar Milrinone (cardiotonic), Sterling Mioflazine HCl (coronary vasodilator), Janssen Nafarelin acetate (LHRH agonist), Syntex Nafimidone HCl (anticonvulsant), Syntex Naflocort (adrenocortical steroid; topical), Squibb Nafazodone HCl (antidepressant), Bristol-Myers Norfloxacin (antibacterial), Merck Octanoic acid (antifungal), Norwich Eaton Oxmetidine mesylate (H[2] antagonist), SK&F Paulomycin (antibacterial), Upjohn Pentafilcon A (contact lens material; hydrophilic), Lombart Pinacidil (antihypertensive), Lilly Polyglyconate (surgical aid; suture material), Maxon, Davis & Geck Propofol (I.V. anesthetic), Diprivan, Stuart Somantadine HCl (antiviral), Pennwalt Sulbactam benzathine (beta lactamase inhibitor), Pfizer Timefurone (anti-atherosclerotic), Upjohn Timobesone acetate (adrenocortical steroid; topical), Syntex Tiprinast meglumine (anti-allergy), Bristol-Myers Tomoxetine HCl (antidepressant), Lilly Trenbolone acetate (anabolic; veterinary), Finaplix, Roussel-UCLAF Trimethoprim sulfate (antibacterial), Burroughs Wellcome Vecuronium bromide (neuromuscular blocking agent), Norcuron, Organon Vinepidine sulfate (antineoplastic), Lilly Xamoterol (cardiac stimulant), Corwin, Stuart Zinoconazole HCl (antifungal), Searle NAME CHANGES OF USAN APPEARING IN USAN 1985 Imipenem (formerly Imipemide), Merck Plicamycin (formerly Mithramycin), Mithracin, Pfizer Zimeldine HCl (formerly Zimelidine HCl), Merck

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