See Table
Table 1.
| Date of approval | Trade name (form) | Generic name(s) | Manufacturer | Indications or use |
|---|---|---|---|---|
| 19 Jan 01 | PEG-Intron (powder for injection) | Peginterferon alpha-2b | Schering Corp. | For treatment of chronic hepatitis C in patients not previously treated with alpha interferon who have compensated liver disease and who are at least 18 yr of age |
| 26 Jan 01 | Cancidas (injection) | Caspofungin acetate | Merck & Co. | Invasive aspergillosis refractory to or intolerant of other therapies |
| 2 Feb 01 | Periostat (tablets) | Doxycycline hyclate | CollaGenex Pharmaceuticals | As an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis |
| 2 Feb 01 | Monistat 3 (emulsion, cream) | Miconazole nitrate | Personal Products Co. | For treatment of vaginal yeast infection and relief of external itching and irritation due to vaginal yeast infection |
| 29 Mar 01 | Valcyte (tablet) | Valganciclovir hydrochloride | Roche Laboratories | For treatment of cytomegalovirus retinitis in patients with AIDS |
| 17 Apr 01 | Sporanox (injection or oral solution) | Itraconazole | Ortho Biotech | For empiric therapy of febrile neutropenic patients with suspected fungal infections |
| 27 Apr 01 | Avelox (tablet) | Moxifloxacin | Bayer Corporation | For uncomplicated skin and skin structure infections |
| 26 Jun 01 | Augmentin ES-600 (powder for reconstitution) | Amoxicillin-clavulanate potassium | GlaxoSmithKline | For treatment of pediatric patients with recurrent or persistent otitis media due to Streptococcus pneumoniae (penicillin MIC ≤2 μg/ml), Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains) and risk factors of antibiotic exposure for acute otitis media within the preceding 3 mo plus age ≤ 2 yr or day care attendance |
| 3 Aug 01 | Biaxin XL (extended-release tablets) | Clarithromycin extended-release tablets | Abbott Laboratories | For treatment of mild to moderate community-acquired pneumonia due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydia pneumoniae, or Mycoplasma pneumoniae in adults |
| 16 Aug 01 | Epivir-HBV (tablets, solution) | Lamivudine | GlaxoSmithKline | For treatment of hepatitis B in pediatric patients ages 2-17 yr |
| 29 Aug 01 | Spectracef (tablets) | Cefditoren pivoxil | TAP Pharmaceutical Products, Inc. | Treatment of acute exacerbation of chronic bronchitis, pharyngitis-tonsillitis, and uncomplicated skin and skin structure infections |
| 12 Oct 01 | Tequin (tablet, injectable) | Gatifloxacin | Bristol-Myers Squibb Co. | For treatment of acute exacerbations of chronic bronchitis for 5 days |
| 26 Oct 01 | Viread (tablet) | Tenofovir disoproxil fumarate | Gilead Sciences, Inc. | For use in combination with other antiretroviral agents for treatment of human immunodeficiency virus type 1 infection in adults |
| 31 Oct 01 | Rebetol (capsule) | Ribavirin | Schering Corporation | Separately available for use in combination with approved biologic product alpha interferon 2b for adult patients with chronic hepatitis C infection |
| 6 Nov 01 | Valtrex (caplets) | Valacyclovir hydrochloride | GlaxoSmithKline | 3-day therapy of recurrent episodes of genital herpes simplex infection |
| 9 Nov 01 | Invanz (intravenous and intramuscular) | Ertapenem sodium | Merck & Co. | For treatment of adult patients with complicated intra-abdominal infections, complicated skin and skin structure infections, community-acquired pneumonia, complicated urinary tract infections including pyelonephritis, acute pelvic infections including postpartum endometritis, septic abortion, and postsurgical gynecologic infections |
| 30 Nov 01 | Avelox (injection) | Moxifloxacin hydrochloride | Bayer Corporation | For treatment of adults (≥ 18 yr of age) with infections caused by susceptible strains of designated microorganisms in the following conditions: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, and uncomplicated skin and skin structure infections |