New Antimicrobial Agents Approved by the U.S. Food and Drug Administration in 1997 and New Indications for Previously Approved Agents
| Date of approval | Trade name (form) | Generic name | Manufacturer | Indications or use |
|---|---|---|---|---|
| 16 Jan 97 | Biaxin (tablet) | Clarithromycin | Abbott Laboratories Pharmaceutical Products Division | New: use in combination with ranitidine bismuth citrate for treatment of patients with an active duodenal ulcer associated with Helicobacter pylori infection |
| 30 Jan 97 | Zithromax (injectable) | Azithromycin | Pfizer Inc. | Treatment of community-acquired pneumonia and pelvic inflammatory disease in patients who require initial intravenous therapy |
| 7 Feb 97 | Femstat One (emulsion) | Butoconazole nitrate | Syntex Laboratories Inc. | Treatment of vulvovaginal infections caused by Candida albicans |
| 11 Feb 97 | Vagistat-1 (ointment) | Tioconazole | Bristol-Myers Products Inc. | Provides for over-the-counter marketing of Vagistat-1 vaginal ointment, 6.5%, 1-day vaginal antifungal treatment regimen for treatment of recurrent vaginal yeast infections (candidiasis) |
| 12 Feb 97 | Unasyn (injectable) | Ampicillin sodium, sulbactam sodium | Pfizer Laboratories, division of Pfizer Inc. | New: treatment of skin and skin structure infections in pediatric patients aged 3 months to 12 years caused by microorganisms previously included in the indications for use |
| 21 Feb 97 | Sporanox (solution) | Itraconazole | Janssen Research Foundation, division of Johnson and Johnson | Treatment of oropharyngeal and esophageal candidiasis |
| 14 Mar 97 | Viracept (tablet and powder) | Nelfinavir mesylate | Agouron Pharmaceuticals Inc. | Treatment of HIVa infection when therapy is warranted |
| 4 Apr 97 | Rescriptor (tablet) | Delavirdine mesylate | Pharmacia and Upjohn Co. | Treatment of HIV-1 infection in combination with appropriate antiretroviral agents when therapy is warranted |
| 16 May 97 | Maxipime (injectable) | Cefepime hydrochloride | Bristol-Myers Squibb Co. Pharmaceutical Research Institute | New: empiric use as monotherapy in febrile neutropenic patients |
| 16 May 97 | Metrogel-Vaginal (gel) | Metronidazole | 3M Pharmaceuticals Inc. | New: once-a-day dosing regimen |
| 30 May 97 | Nizoral (shampoo) | Ketoconazole | Janssen Research Foundation, division of Johnson and Johnson | New: treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare) |
| 3 Jun 97 | Cipro (tablet) | Ciprofloxacin hydrochloride | Bayer Corp. | New: for treatment of acute sinusitis |
| 21 Jul 97 | Loprox (gel) | Ciclopirox | Hoechst Marion Roussel Inc. | Topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum and topical treatment of seborrheic dermatitis of the scalp |
| 7 Aug 97 | Cipro (injectable) | Ciprofloxacin hydrochloride | Bayer Corp. | New: empirical therapy for febrile neutropenic patients |
| 11 Aug 97 | Ambisome (injectable) | Amphotericin B | Fujisawa USA Inc. | Empirical therapy of presumed fungal infection in febrile, neutropenic patients; treatment of patients with Aspergillus species, Candida species, and/or Cryptococcus species infections refractory to amphotericin B deoxycholate or of patients for whom renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate; and treatment of visceral leishmaniasis |
| 18 Aug 97 | Oxistat (cream) | Oxiconazole nitrate | Glaxo Wellcome Inc. | New: treatment of tinea (pityriasis) versicolor |
| 16 Sept 97 | Biaxin (tablet) | Clarithromycin | Abbott Laboratories Pharmaceutical Products Division | New: addition of a new therapy regimen to an existing indication; treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of duodenal ulcer) to eradicate H. pylori infection in combination with lansoprazole and amoxicillin |
| 17 Sept 97 | Famvir (tablet) | Famciclovir | SmithKline Beecham Pharmaceuticals Co. | New: suppression of recurrent episodes of genital herpes in immunocompetent adults |
| 17 Sept 97 | Ceftin (tablet) | Cefuroxime axetil | Glaxo Wellcome Inc. | New: treatment of secondary bacterial infections of acute bronchitis with 5-day therapy |
| 26 Sept 97 | Combivir (tablet) | Lamivudine, zidovudine | Glaxo Wellcome Inc. | Treatment of HIV infection |
| 26 Sept 97 | Cipro (suspension) | Ciprofloxacin hydrochloride | Bayer Corporation Pharmaceutical Division | A new formulation with indications of acute sinusitis, lower respiratory tract infections, urinary tract infections, acute uncomplicated cystitis in females, chronic bacterial prostatitis, complicated intra-abdominal infections, skin and skin structure infections, bone and joint infections, infectious diarrhea, typhoid fever (enteric fever), and uncomplicated cervical and urethral gonorrhea |
| 26 Sept 97 | Noritate (cream) | Metronidazole | Dermik Laboratories Inc. | Topical treatment of inflammatory lesions and erythema of rosacea |
| 26 Sept 97 | Valtrex (tablet) | Valacyclovir hydrochloride | Glaxo Wellcome Inc. | New: suppression of recurrent episodes of genital herpes in immunocompetent adults |
| 1 Oct 97 | Nebcin (injectable) | Tobramycin sulfate | Eli Lilly and Co. | New: specific dosing of patients with cystic fibrosis |
| 10 Oct 97 | Nizoral A-D (shampoo) | Ketoconazole | Johnson and Johnson Consumer Products Inc. | Control of flaking, scaling, and itching associated with dandruff |
| 17 Oct 97 | Lamisil (solution) | Terbinafine hydrochloride | Novartis Pharmaceuticals Corporation | Topical treatment of tinea (pityriasis) versicolor due to M. furfur (formerly Pityrosporum ovale) and tinea pedis (athlete’s foot), tinea cruris (jock itch), or tinea corporis (ringworm) due to T. rubrum, T. mentagrophytes, or E. floccosum |
| 6 Nov 97 | Raxar (tablet) | Grepafloxacin hydrochloride | Glaxo Wellcome Inc. | Treatment of acute bacterial exacerbations of chronic bronchitis, community-acquired pneumonia, uncomplicated gonorrhea (urethral in males and endocervical and rectal in females), and nongonococcal urethritis and cervicitis |
| 25 Nov 97 | Mentax (cream) | Butenafine hydrochloride | Penederm Inc. | New: 1-week dosing of interdigital tinea pedis |
| 11 Dec 97 | Timentin (injectable) | Clavulanate potassium, ticarcillin disodium | SmithKline Beecham Pharmaceuticals | New: for use in pediatric patients |
| 11 Dec 97 | Bactroban (cream) | Mupirocin calcium | SmithKline Beecham Pharmaceuticals | Treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes |
| 16 Dec 97 | Floxin Otic (solution/drops) | Ofloxacin | Daiichi Pharmaceutical Co. Ltd. | Treatment of otitis externa, chronic suppurative otitis media, and acute otitis media in patients with tympanostomy tubes |
| 18 Dec 97 | Trovan (tablet) | Trovafloxacin mesylate | Pfizer Central Research | Broad-spectrum antibacterial agent indicated for treatment of infections caused by susceptible strains of microorganisms |
| 18 Dec 97 | Trovan (injectable) | Alatrofloxacin mesylate | Pfizer Central Research | Broad-spectrum antibacterial agent indicated for treatment of infections caused by susceptible strains of microorganisms |
| 19 Dec 97 | Dynabac (tablet) | Dirithromycin | Eli Lilly and Co. | New: 5-day use for treatment of patients with acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae and for treatment of patients with uncomplicated skin and skin structure infections due to S. aureus (methicillin-susceptible strains) or S. pyogenes. Also provides for the addition of H. influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis |
| 22 Dec 97 | Banan (tablet or granule, for reconstitution) | Cefpodoxime proxetil | Sankyo USA Corp. | New: for acute exacerbations of chronic bronchitis caused by S. pneumoniae, H. influenzae (including beta-lactamase-producing strains), Haemophilus parainfluenzae, or M. catarrhalis |
| 22 Dec 97 | Tobi (solution) | Tobramycin | Pathogenesis Corp. | Management of cystic fibrosis patients with Pseudomonas aeruginosa |
| 23 Dec 97 | Rocephin (injectable) | Ceftriaxone sodium | Hoffmann-La Roche Inc. | New: single-dose therapy for treatment of acute otitis media |
a
HIV, human immunodeficiency virus.