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FOUR QUINOLONE ANTIBIOTICS LISTED FOR FIRST TIME IN 1988 EDITION OF USAN AND USP DICTIONARY; WYETH-AYERST HAS MORE NEW LISTINGS THAN ANY OTHER COMPANY

Executive Summary

Four new quinolone antibiotics -- Miles' ciprofloxacin, Abbott's difloxacin, Rhone-Poulenc's pefloxacin, and Roche's fleroxacin -- are among 17 antibacterial and antifungal drug products listed for the first time in the 1988 edition of the USAN and USP Dictionary of Drug Names. The newcomers reflect an industry-wide interest in the new broad-spectrum anti-infective class. With an NDA pending at FDA, Miles' ciprofloxacin is furthest along of the four quinolones. Clinical reports indicate that the Miles' antibiotic is one of the more potent quinolone antibiotics now emerging from the pipeline. Further back in clinical trials are Abbott's difloxacin and Roche's fleroxacin. Roche's oral formulation of fleroxacin is in Phase II studies, and an intravenous formulation is in Phase I. Roche is seeking oral fleroxacin indications in bacterial enteritis, bone and joint infections, urinary tract infections, skin and soft tissue infections, sexually transmitted diseases, and lower respiratory tract infections. Merck's Noroxin (norfloxacin) was the first quinolone antibiotic to be approved by FDA in October of last year. As a class, the 17 antibacterial/antifungal compounds represent the largest therapeutic category among the 123 new first-time listings. In addition to the quinolones, the antibacterial group has four cephalosporins: Bristol-Myers cefepime; Fujisawa's cefixime (licensed to Lederle); Upjohn's cefmetazole; and Wyeth's cefpiramide. Cefmetazole is currently in clinical trials, with an NDA filing targeted for 1988. New cardiovascular drug listings are second to antibacterials with 13 entries, followed by anti-inflammatory drugs (12 new listings), antivirals (seven listings), anti-ulcer agents (six listings), and antineoplastic compounds (six listings) [For a full list of all new entries in the 1988 USAN dictionary, see chart on pages 8-9]. Recently combined Wyeth-Ayerst, with 11 new entries, leads all companies in terms of new listings. In addition to the antibacterial cefpiramide, Wyeth new entities in active clinical development include the antihypertensive anaritide acetate, in Phase II, and the antidepressant minaprine, licensed from Sanofi. Roche and Schering follow Wyeth-Ayerst with six new entries, and Sandoz, Synthelabo, and Upjohn each have four new human compounds listed. First-time listings in this year's USAN and USP dictionary far surpassed recent years, with 34 more names than in 1987 and more than double most recent editions. Of the 123 new entries, 118 are human pharmaceutical compounds, and 99 are new chemical entities. Rorer and its 1986 acquisition, USV, together have four new listings, including lofepramine, an antidepressant, and eclazolast, an anti-allergic. Rorer's current acquisition target, Robins, also has four new listings. Robins' analgesic bromfenac, anti-arrhythmic suricainide and antidepressant tampramine are all in clinicals. Robins' other new entry, the antiemetic zacopride, is in the preclinical stage of development. The preface to the USP dictionary explains that a USAN (U.S. adopted name) listing "originates from a firm or an individual who has developed a substance of potential therapeutic utility to the point where there is a distinct possibility of its being marketed in the U.S." However, initial listing in the USAN and USP dictionary does not necessarily mean that a drug is in the pre-NDA stage. For example, Merck's Mevacor (lovastatin), Wyeth's Cordarone (amiodarone), and Schering's Elocon (mometasone) are all listed for the first time in the 1988 edition of the USAN and USP dictionary even though each of these products has been approved for marketing by FDA. Elocon was launched in the U.S. Sept. 8, while Mevacor is expected to reach pharmacies beginning Sept. 14. Also, listed drugs may represent inactive or discontinued research projects. The 1988 edition includes 2,529 listings for U.S. adopted names for pharmaceutical compounds from June 15, 1961, through June 15, 1987. Also included are 5,105 international nonproprietary names compiled by the World Health Organization from 1953 to 1986. Overall, the dictionary has more than 24,000 entries. The dictionary is available from USP for $69.50. Copies may be obtained by writing to the USPC Order Processing Department, 12601 Twinbrook Parkway, Rockville, Md., 20852. NEW U.S. ADOPTED NAMES (USAN) INCLUDED IN THE 1988 EDITION OF USAN AND THE USP DICTIONARY OF DRUG NAMES Acitretin (antipsoriatic), Roche Alpidem (anxiolytic), Synthelabo Amiodarone (anti-arrhythmic, ventricular), Cordarone, Wyeth Amiprilose HCl (antibacterial; antifungal; anti-inflammatory; antineoplastic; antiviral; immunomodulator), Therafectin, Greenwich Anaritide Acetate (antihypertensive; diuretic), Wyeth Apalcillin Sodium (antibacterial), Wyeth Azumolene Sodium (skeletal muscle relaxant), Norwich Eaton Bemitradine (antihypertensive; diuretic), Searle Bisoprolol (antihypertensive; beta-blocker), Lederle Bisoprolol Fumarate (antihypertensive; beta-blocker), Lederle Bispyrithione Magsulfex (antibacterial; antifungal; antidandruff), Omadine MDS, Olin Bromfenac Sodium (analgesic), Robins Bropirimine (antineoplastic; antiviral), Upjohn Bucromarone (anti-arrhythmic), Squibb (licensed from Transphyto) Butaprost (bronchodilator), Miles Cefepime (antibacterial), Bristol-Myers Cefixime (antibacterial), Fujisawa, Japan Cefmetazole Sodium (antibacterial), Upjohn (licensed from Sankyo) Cefpiramide (antibacterial), Wyeth Cefpiramide Sodium (antibacterial), Wyeth Chlorpheniramine Polistirex (antihistaminic), component of Penntuss, Pennwalt Ciclazindol (antidepressant), Wyeth Cimetidine HCl (H[2] antagonist), Tagamet, SmithKline Ciprofloxacin (antibacterial), Miles Ciprofloxacin HCl (antibacterial), Miles Clebopride (anti-emetic), Cleboril, Laboratorios Almirall (Spain) Codeine Polistirex (antitussive), component of Penntuss, Pennwalt Dazepinil HCl (antidepressant), Hoechst-Roussel Declaben (anti-arthritic; emphysema therapy adjunct), Searle Deflazacort (anti-inflammatory), Merrell Dow Desciclovir (antiviral), Burroughs Wellcome Detirelix Acetate (LHRH antagonist), Syntex Dexamethasone Acefurate (steroid, topical), Schering Dexamethasone Dipropionate (anti-inflammatory, steroid), Hovione (Portugal) Dextromethorphan Polistirex (antitussive), Delsym, Pennwalt; McNeil Difloxacin HCl (anti-infective; DNA gyrase inhibitor), Abbott Disiquonium Chloride (antiseptic), Sanitized Disoxaril (antiviral), Sterling Dobutamine Tartrate (cardiotonic), Lilly Donetidine (H[2] antagonist), SmithKline Doxycycline Fosfatex (antibacterial), Vibramycin analog, Hovione (Portugal) Ebastine (antihistaminic), Laboratories Almirall (Spain) Eclanamine Maleate (antidepressant), Upjohn Eclazolast (anti-allergic; mediator release inhibitor), USV (now Rorer) Edifolone Acetate (anti-arrhythmic), Searle Esorubicin HCl (antineoplastic), Farmitalia Carlo Erba (Italy) Etofenamate (analgesic; anti-inflammatory), Rorer Fazarabine (antineoplastic) Felbinac (anti-inflammatory), Lederle Fengabine (mood regulator), Synthelabo Fleroxacin (antibacterial), Roche Flumazenil (benzodiazepine antagonist), Roche Fostriecin Sodium (antineoplastic), Parke-Davis Goserelin (LHRH agonist), Zoladex, Stuart Hydralazine Polistirex (antihypertensive), Vasodur, Pennwalt Hydrocodone Polistirex (antitussive), component of Tussionex, Pennwalt Idarubicin HCl (antineoplastic), Farmitalia Carlo Erba Imazodan HCl (cardiotonic), Parke-Davis Indomethacin Sodium (anti-inflammatory), Merck Interferon Alfa-2a (antineoplatic; antiviral), Roferon-A, Roche Interferon Alfa-2b (antineoplastic; antiviral), Intron-A, Schering Interferon Alfa-n1 (antineoplastic; antiviral), Wellferon, Burroughs Wellcome Interferon Gamma-1b (antineoplastic; antiviral), Genentech Iopentol (diagnostic aid; radiopaque medium), Nycomed (Norway) Ioversol (diagnostic aid; radiopaque medium), Mallinckrodt Isepamicin (aminoglycoside), Schering Isotiquimide (anti-ulcerative), Wyeth Isradipine (calcium channel antagonist), Sandoz Lofepramine HCl (antidepressant), Rorer Lovastatin (antihypercholesteremic), Mevacor, Merck Methylprednisolone Suleptanate (anti-inflammatory), Upjohn Mexiletine HCl (cardiac depressant; anti-arrhythmic), Mexitil, Boehringer Ingelheim Minaprine HCl (antidepressant), Wyeth (licensed from Sanofi) Moclobemide (antidepressant) Roche Mometasone Furoate (topical steroid), Elocon, Schering Mupirocin (topical antibacterial), Beecham Nabumetone (anti-inflammatory), Beecham Nedocromil Calcium (anti-allergic), Fisons Octreotide (gastric anti-secretory), Sandoz Olsalazine Sodium (anti-inflammatory), Pharmacia AB Olvanil (analgesic), Norwich Eaton Oxendolone (anti-androgen), Takeda Oxiconazole Nitrate (antifungal), Siegfried AG, (Switzerland) Paldimycin (antibacterial), Upjohn Pefloxacin Mesylate (antibacterial), Rhone-Poulenc Penamecillin (antibacterial), Wyeth Pentastarch (leukopheresis adjunct), DuPont Critical Care Pentiapine Maleate (antipsychotic), Ciba-Geigy Permethrin (ectoparasiticide), Nix, Burroughs Wellcome Phenylpropanolamine Polistirex (adrenergic; vasoconstrictor), Pennwalt Pipecuronium Bromide (muscle relaxant), Gedeon Richter (Hungary) Pirenzepine HCl (anti-ulcerative), Boehringer Ingelheim Piridronate Sodium (calcium regulator), Norwich Eaton Piroxicam Cinnamate (anti-inflammatory), Societa Prodotti Antibiotici (Italy) Pseudoephedrine Polistirex (nasal decongestant), Pennwalt Rolgamidine (antidiarrheal), Wyeth Roxithromycin (antibacterial), Hoechst-Roussel Spirapril HCl (ACE inhibitor), Schering Sufotidine (H[2] antagonist), Glaxo Suricainide Maleate (anti-arrhythmic), Robins Tampramine Fumarate (antidepressant), Robins Temelastine (antihistaminic), SmithKline Tenoxicam (anti-inflammatory), Roche Terbinafine (antifungal), Sandoz Teriparatide Acetate (diagnostic aid -- hypocalcemia), USV (now Rorer) Tifurac Sodium (analgesic), Syntex Tilomisole (immunoregulator), Wyeth Tixocortol Pivalate (topical anti-inflammatory), Sandoz (licensed from Jouveinal) Tolgabide (antiepileptic), Synthelabo Tolofocon A (hydrophobic contact lens material), Toyo Topiramate (anticonvulsant), McNeil Triptorelin (antineoplastic), Lederle (licensed from Baehen) Tropanserin HCl (serotonin receptor antagonist), Merrell Dow Urofollitropin (follicle-stimulating hormone), Metrodin, Serono Vifilcon B (hydrophilic contact lens material), Softcon, Parke-Davis Zacopride HCl (anti-emetic), Robins Zidovudine (antiviral), Retrovir, Burroughs Wellcome Zolpidem Tartrate (hypnotic; sedative), Synthelabo
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