| 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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