| TABLES Table 1
|
 New Drugs of 1999Tables
|
| Generic Name | Brand Name | Company | Approved Indication |
| litretinoin gel 0.1% | Panretin | Ligand Pharmaceuticals Inc. | AIDS-related Kaposi’s sarcoma |
| Aminolevulinic acid HCl | Levulan Kerastick | Guidelines Inc. | Photodynamic therapy of actinic keratosis of the face and scalp |
| Amprenavir | Agenerase | Glaxo Wellcome Inc. | Treatment of HIV-1 infection |
| Bexarotene | Targretin | Ligand Pharmaceuticals Inc | Refractory patients with cutaneous manifestations of T-cell lymphoma |
| Cilostazol | Pletal | Otsuka Pharmaceuticals | Reduction of symptoms of intermittent claudication |
| Dalfopristin/quinupristin injection | Synercid | Rhone-Poulenc Rorer Pharmaceuticals, Inc. | Complicated skin & skin structure infections, also treatment of vancomycin-resistant Enterococcus faceum |
| Denileukin diftitox injection | Ontak | Seragen Inc. | Persistent or recurrent cutaneous injection T-cell lymphoma with CD25 expression of the IL-2 receptor |
| Dexmedetomidine HCl injection | Precedex | Abbott Laboratories | Sedation of intubated and mechanically ventilated patients during treatment in an ICU setting |
| Dofetilide | Tikosyn | Pfizer Inc. | Atrial fibrillation and atrial flutter |
| Doxercalciferol | Hectorol | Bone Care | Reduction of PTH levels in dialysis patients with secondary hyperparathyroidism |
| Entacapone | Comtan | Orion Corp/Novartis | Adjunct to levodopa/carbidopa in fluctuating patients with idiopath Parkinson's disease |
| Epirubicin HCl injection | Ellence | Pharmacia & Upjohn Co. | A component of adjuvant therapy in patients with axillary node tumor evolvement following resection of primary breast cancer |
| Exemestane | Aromasin | Pharmacia & Upjohn Co. | Advanced breast cancer in postmenopausal patients who have failed tamoxifen therapy |
| Ferric sodium gluconate injection | Ferrlecit | R & D Laboratories Inc. | Treatment of iron deficiency anemia in chronic hemodialysis patients receiving erythropoeitin |
| Gadoversetamide | Optimark | Mallinckrodt Inc. | Contrast enhancement for magnetic resonance imaging |
| Ganirelix acetate | Antagon | Organon Inc. | Inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation |
| Gatifloxacin tablets & injection | Tequin | Bristol-Myers Squibb | Numerous infectious indications |
| Interferon alfa-n1, lymphoblastoid | Wellferon | Glaxo Wellcome Inc. | Chronic hepatitis C |
| Ketotifen fumarate ophthalmic solution 0.025% | Zaditor | Ciba Vision | Prevention of eye itching due to allergic conjunctivitis |
| Mequinol/tretinoin | Solage | Bristol-Myers Squibb | Solar lentigines |
| Moxifloxacin HCl | Avelox | Bayer Corporation | Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis & community-acquired pnemonia |
| Nitric oxide | Inomax | INO Therapeutics Inc. | Treatment of neonates with hypoxic respiratory failure associated with pulmonary hypertension |
| Orlistat | Xenical | Hoffmann LaRoche | Obesity management |
| Oseltamivir phosphate ophthalmic solution 0.1% | Tamiflu | Hoffmann LaRoche | Uncomplicated acute illness due to influenza virus |
| Pemirolast potassium | Alamast | Santen Inc. | Prevention of eye itching due to allergic conjunctivitis |
| Pioglitazone HCl | Actos | Takeda America/Eli Lilly Inc. | Treatment of type 2 diabetes |
| Poractant alpha | Curosurf | Dey Laboratories | Treatment of respiratory distress syndrome in premature infants |
| Rabeprazole sodium | Aciphex | Eisai Inc. | Healing & maintenance of erosive or ulcerative GERD. Healing of duodenal ulcers and treatment of pathological hypersecretory conditions |
| Rapacuronium bromide | Raplon | Organon Inc. | Adjunct to general anesthesia to facilitate trachael intubation and skeletal muscle relaxation for surgery |
| Rofecoxib | Vioxx | Merck & Co., Inc. | Osteoarthritis, management of acute pain & primary dysmenorrhea |
| Rosiglitazone maleate | Avandia | SmithKline Beecham Pharmaceuticals | Treatment of type 2 diabetes |
| Sirolimus | Rapamune | Wyeth-Ayerst Laboratories | Prophylaxis of organ rejection in kidney transplant recipients |
| Technetium Tc-99M depreotide | Neotect | Diatide Inc. | Detection of pulmonary lesions on computed tomography in patients with known or highly suspected malignancy |
| Temozolomide | Temodar | Schering Corporation | Refractory anaplastic astrocytoma |
| Zaleplon | Sonata | Wyeth-Ayerst Laboratories | Short-term treatment of insomnia |
| Zanamivir | Relenza | Glaxo Wellcome Inc. | Uncomplicated acute illness due to influenza virus |
Table 2. New Formulation Approvals for 1999
A new dosage form or new formulation of an active ingredient already on the market
| Generic Name | Brand Name | Company | Approved Indication |
| Amoxicillin suspension | Amoxil | SmithKline Beecham Pharmaceuticals | New 200 mg/5 mL and 400 mg/5 mL strengths for twice-daily dosing |
| Betamethasone valerate | Luxiq | Connetics Corp. | Inflammatory and pruritic manifestations of dermatoses of the scalp |
| Budesonide metered aerosol | Rhinocort Aqua | Astra Pharmaceuticals | Seasonal and perennial allergic rhinitis |
| Busulfan injection | Busulfex | Orphan Medical, Inc. | In combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia |
| Ciclopirox solution | Penlac | Hoechst Marion Roussel | Onychomycosis of the fingernails and toenails due to trichophyton rubrum |
| Citalopram HCl solution | Celexa | Forest Laboratories, Inc. | Depression |
| Clindamycin phosphate vaginal ovules | Cleocin | Pharmacia & Upjohn Co. | Bacterial vaginosis |
| Cytarabine liposome injection | Depocyt | Depotech Corp | Intrathecal treatment of lymphomatous meningitis |
| Estradiol tablets | Vagifem | Novo Nordisk Pharmaceuticals Inc. | Relief of postmenopausal atrophic vaginitis due to estrogen deficiency |
| Estradiol; Estradiol/ norgestimate table | Ortho-Prefest | RW Johnson Pharmaceutical Research Institute | Moderate-to-severe vasomotor symptoms of menopause, treatment of vulvar & vaginal atrophy |
| Estradiol transdermal patch | Estradiol Transdermal System | Wyeth-Ayerst Laboratories | Moderate to severe vasomotor symptoms of menupause and treatment of vulvar & vaginal atrophy |
| Estrogens, conjugated tablets | Cenestin | Duramed Phamaceuticals, Inc. | Moderate-to-severe vasomotor symptoms of menopause |
| Ethinyl estradiol/norethindrone acetate tablets | FemHRT | Parke-Davis | Moderate-to-severe vasomotor symptoms of menopause and prevention of osteoporosis |
| Itraconazole injection | Sporanox | Janssen | Treatment of blastomycosis, histoplasmosis & aspergillosis |
| Levalbuterol HCl inhalation solution | Xopenex | Sepracor Pharmaceutica Inc. | Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease |
| Levonorgestrel tablets | Plan B | Womens Capital Corp. | Emergency contraception |
| Lidocaine extended release film | Lidoderm | Hind Health Care | Post-herpetic neuralgia pain |
| Methoxsalen solution | Uvadex | Therakos Inc. | Palliative treatment of the skin manifestations of cutaneous T-cell lymphoma unresponsive to other therapy |
| Miconazole nitrate dual pak | Monistat Dual-Pak | Advanced Care Products | Vulvovaginal candidiasis |
| Multivitamin 12 injection powder for reconstitution | Cernevit-12 | Baxter Healthcare Corporation | Multivitamin maintenance for patients receiving parenteral nutrition |
| Ondansetron orally disintegrating tablet | Zofran ODT | Glaxo Wellcome Inc. | Prevention of chemotherapy and radiation-induced nausea & vomiting |
| Paroxetine HCl controlled release | Paxil CR | SmithKline Beecham Pharmaceuticals | Depression |
| Polyethylene glycol 3350 powder for reconstitution | Miralax | Braintree Laboratories, Inc. | Treatment of occasional constipation |
| Ritonavir soft gelatin capsules | Norvir | Abbott Laboratories | HIV infection |
| Sertraline concentrate | Zoloft | Pfizer Inc. | Depression, OCD, and panic disorder |
Table 3. New Combination Approvals for 1999
Drugs that contain two or more compounds, the combination of which has not been marketed together in a product
| Generic Name | Brand Name | Company | Approved Indication |
| Aspirin/dipyridamole | Aggrenox | Boehringer Ingelheim Pharmaceuticals, Inc. | Reduce the risk of stroke in patients with transient ischemic attacks or complete ischemic stroke due to thrombosis |
Table 4. New Derivative Approvals for 1999
A chemical derived from an active ingredient already marketed as a “parent drug”
| Generic Name | Brand Name | Company | Approved Indication |
| Caffeine | Cafcit | Oread Pediatric | Short-term treatment of apnea of prematurity in infants between 28 & 33 weeks' gestational age |
| Levobupivacaine HCl injection | Chirocaine | Darwin Discovery LTD | Surgical anesthesia and pain management for adults |
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