New Antimicrobial Agents Approved by the U.S. Food and Drug Administration in 1998 and New Indications for Previously Approved Agents

Date of approval	Trade name (form)	Generic name(s)	Manufacturer	Indications or use
8 Jan 98	Vancocin HCl (injectable)	Vancomycin hydrochloride	Baxter Healthcare Corporation	New: provides for specific dosing of premature neonates
30 Jan 98	Maxipime (injectable)	Cefepime hydrochloride	Bristol Myers Squibb Co.	New: provides for additional use of cefepime in combination with metronidazole for treatment of complicated intra-abdominal infections
6 Feb 98	Crixivan (capsule)	Indinavir sulfate	Merck Research Laboratories	New: indicated for the treatment of HIV infection in combination with antiretroviral agents
10 Feb 98	Cipro HC (suspension/drops)	Ciprofloxacin hydrochloride; hydrocortisone	Bayer Corp.	Treatment of acute otitis externa
24 Feb 98	Zosyn (injectable)	Piperacillin sodium; tazobactam sodium	Lederle Piperacillin Inc.	Treatment of patients with moderate-to-severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, β-lactamase-producing strains of designated microorganisms and conditions specified in the labeling
27 Feb 98	Amoxil (capsule; tablet, chewable powder for reconstitution)	Amoxicillin	SmithKline Beecham Pharmaceuticals	New: for use in combination with lansoprazole (with or without clarithromycin) in patients with duodenal ulcer (defined as an active ulcer or history of an ulcer within 1 year) to eradicate Helicobacter pylori and reduce the risk of duodenal ulcer recurrence
2 Mar 98	Cleocin (cream)	Clindamycin phosphate	Pharmacia and Upjohn Co.	New: provides for a 3-day dosing regimen of 2% clindamycin phosphate vaginal cream in the treatment of bacterial vaginosis
30 Mar 98	Monistat 3 (cream)	Miconazole nitrate	Advanced Care Products	For over-the-counter treatment of vulvovaginal candidiasis
30 Mar 98	Ciloxan (ointment)	Ciprofloxacin hydrochloride	Alcon Laboratories Inc.	Treatment of bacterial conjunctivitis caused by susceptible strains of designated microorganisms
3 Apr 98	Cipro in sodium chloride 0.9% in plastic container (injectable)	Ciprofloxacin	Bayer Corp.	New: provides for the addition of information pertaining to the use in cystic fibrosis patients to the pediatric-use subsection of the labeling
3 Apr 98	Cipro in dextrose 5% in plastic container (injectable)	Ciprofloxacin	Bayer Corp.	New: provides for the addition of information pertaining to the use in cystic fibrosis patients to the pediatric-use subsection of the labeling
3 Apr 98	Cipro (injectable)	Ciprofloxacin	Bayer Corp.	New: provides for the addition of information pertaining to the use in cystic fibrosis patients to the pediatric-use subsection of the labeling
3 Apr 98	Cipro (tablet)	Ciprofloxacin hydrochloride	Bayer Corp.	New: provides for the addition of information pertaining to the use in cystic fibrosis patients to the pediatric-use subsection of the labeling
8 Apr 98	Primaxin (injectable)	Cilastatin sodium; imipenem	Merck Sharp and Dohme	New: treatment of serious infections caused by susceptible strains of designated microorganisms in pediatric patients
29 Apr 98	Lamisil (gel)	Terbinafine	Novartis Pharmaceuticals Corp.	Topical treatment of the following dermatologic infections: tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum ovale), tinea pedis (athlete’s foot), or tinea corporis (ringworm), due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum

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Date of approval	Trade name (form)	Generic name(s)	Manufacturer	Indications or use
20 May 98	Viramune (tablet)	Nevirapine	Boehringer Ingelheim Pharmaceuticals	New: provides for a change in the indication as follows: “viramune is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection”
2 Jun 98	Zovirax (injectable)	Acyclovir sodium	Glaxo Wellcome Inc.	New: treatment of herpes simplex virus infections in neonatal patients
3 Jun 98	Intron A/Rebetol (injectable/capsule)	Interferon Alfa-2b, recombinant/ribavirin	Schering Corp.	Treatment of chronic hepatitis C in patients with compensated liver disease who have relapsed following alpha interferon therapy
5 Jun 98	Sulfamylon (powder, for reconstitution)	Mafenide acetate	Mylan Laboratories Inc.	Adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds
22 Jun 98	Priftin (tablet)	Rifapentine	Hoechst Marion Roussel Inc.	Treatment of pulmonary tuberculosis
26 Aug 98	Vitravene (injectable)	Fomivirsen sodium	Isis Pharmaceuticals Inc.	Local treatment of cytomegalovirus (CMV) retinitis in patients with AIDS who are intolerant of or have a contraindication to other treatment(s) for CMV retinitis or who were insufficiently responsive to previous treatment(s) for CMV retinitis
3 Sep 98	Atridox (drug delivery system)	Doxycycline hyclate	Atrix Laboratories Inc.	For treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing
11 Sep 98	Viramune (tablet; suspension)	Nevirapine	Boehringer Ingelheim Pharmaceuticals Inc.	New: for use in combination therapy with other antiretroviral agents for treatment of HIV-1 infection
16 Sep 98	Biaxin (tablet)	Clarithromycin	Abbott Laboratories	New: for use of Biaxin (clarithromycin) filmtab tablets in combination with Prilosec delayed-release (omeprazole) capsules and amoxicillin, as triple therapy for treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or 1-year history of duodenal ulcer) to eradicate Helicobacter pylori
17 Sep 98	Sustiva (capsule)	Efavirenz	Dupont Merck Pharmaceutical Co.	Treatment of HIV-1 infection
24 Sep 98	Cipro in sodium chloride 0.9% (injectable)	Ciprofloxacin	Bayer Corp.	New: for treatment of acute sinusitis and chronic bacterial prostatitis infections
24 Sep 98	Cipro in dextrose 5% (injectable)	Ciprofloxacin	Bayer Corp.	New: for treatment of acute sinusitis and chronic bacterial prostatitis infections
24 Sep 98	Cipro (injectable)	Ciprofloxacin	Bayer Corp.	New: for treatment of acute sinusitis and chronic bacterial prostatitis infections
30 Sep 98	Periostat (capsule)	Doxycycline hyclate	Collagenex Inc.	To promote attachment level gain and to reduce pocket depth in patients with adult periodontitis
24 Nov 98	Metrolotion (lotion)	Metronidazole	Galderma Laboratories Inc.	For treatment of inflammatory papules and pustules of rosacea
24 Nov 98	Gyne-lotrimin 3 (cream)	Clotrimazole	Schering Plough Healthcare Products Inc.	For treatment of vulvovaginal candidiasis
8 Dec 98	Epivir-HBV (solution; tablet)	Lamivudine	Glaxo Wellcome Inc.	For treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation
17 Dec 98	Levaquin (injectable; tablet)	Levofloxacin	R. W. Johnson Pharmaceutical Research Institute	New: for treatment of uncomplicated urinary tract infections
18 Dec 98	Trovan/Zithromax Compliance Pak (tablet)	Trovafloxacin mesylate, azithromycin	Pfizer Pharmaceuticals Inc.	For treatment of two sexually transmitted diseases