Updated through December 31, 2000
|NDA Number||Proprietary Name||Established Name||Applicant||Review Classification||Approval Date||Indication|
|Evoxac||Cevimeline Hydrochloride||ShowBrand||S||11-Jan-00|| |
Evoxac is indicated for the treatment of symptoms of dry mouth in patients with Sjogren’s Syndrome.
|Trileptal||Oxcarbazepine||Novartis Pharms||S||14-Jan-00||Trileptal is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults with epilepsy and as adjunctive therapy in the treatment of partial seizures in children ages 4-16 with epilepsy.|
|Protonix||Pantoprazole Sodium||Wyeth-Ayerst||S||02-Feb-00||Protonix is indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD).|
|Lotronex||Alosetron Hydrochloride||Glaxo Wellcome||P||09-Feb-00||Lotronex is indicated for the treatment of irritable bowel syndrome (IBS) in female patients whose predominant bowel symptom is diarrhea.|
|Skin Exposure Reduction Paste Against Chemical Warfare Agents||Perfluoro-polymethyl-isopropyl Ether; Polytetrafluoro-ethylene||U.S. Army||P||17-Feb-00||Provides for the use of SERPACWA only in conjunction with Mission Oriented Protective Posture (MOPP) gear to reduce or delay the absorption of chemical warfare agents through the skin when SERPACWA is applied prior to exposure.|
|N020789||Zonegran||Zonisamide||Dainippon Pharm||S||27-Mar-00||Zonegran is used as an adjunctive therapy in the treatment of partial seizures in adults with epilepsy.|
|Septocaine||Articaine Hydrochloride, Epinephrine||Deproco||S||03-Apr-00||Septocaine is indicated for infiltration or nerve block anesthesia for dentistry.|
|Visudyne||Verteporfin||QLT Photo||P||12-Apr-00||Visudyne provides for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.|
|N020938||Mobic||Meloxicam||Boehringer Ingleheim Pharms||S||13-Apr-00||Mobic is indicated for the relief of the signs and symptoms of osteoarthritis.|
|N021130||Zyvox||Linezolid||Pharmacia & Upjohn||P||18-Apr-00||Zyvox is indicated for the treatment of adult patients with vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, complicated and uncomplicated skin and skin structure infections, and community-acquired pneumonia.|
|N021081||Lantus||Insulin Glargine||Aventis Pharms||S||20-Apr-00||Lantus is indicated for once-daily subcutaneous administration at bedtime in the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.|
|N020823||Exelon||Rivastigmine Tartrate||Novartis Pharms||S||21-Apr-00||Exelon is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.|
|N021174||Mylotarg||Gemtuzumab Ozogamicin||Wyeth-Ayerst||P, O||17-May-00||Mylotarg is indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy.|
|N021176||Welchol||Colesevelam Hydrochloride||Sankyo Pharm||S||26-May-00||Welchol is indicated for the reduction of elevated LDL-cholesterol, alone or in combination with an HMG-CoA reductase inhibitor, in patients with primary hypercholesterolemia (Frederickson Type IIa).|
|N020986||NovoLog||Insulin Aspart Recombinant||Novo Nordisk||S||07-Jun-00||NovoLog is indicated for the treatment of adult patients with diabetes mellitus, for the control of hyperglycemia.|
|N020715||Trelstar Depot||Triptorelin Pamoate||Debio Recherche||S||15-Jun-00||Trelstar Depot is indicated for the palliative treatment of advanced prostate cancer.|
|N020883||Acova||Argatroban||Texas Biotech||S||30-Jun-00||Acova is indicated as an anticoagulant for prophylaxis or treatment of thrombosis patients with heparin-induced thrombocytopenia.|
|N020484||Innohep||Tinzaparin Sodium||Dupont||S||14-July-00||Innohep is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium.|
|N020610||Colazal||Balsalazide Disodium)||Salix Pharm||S||18-Jul-00||Colazal is indicated for the treatment of mildly to moderate active ulcerative colitis.|
|N020941||Abreva||Docosanol||SKB Cons Healthcare||S||25-Jul-00||Abreva is indicated for the treatment of cold sores and fever blisters.|
|N021214||Rescula||Unoprostone Isopropyl||Ciba Vision||P||03-Aug-00||Rescula is indicated for the lowering of intraocular pressure in patients with open-angel glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication.|
|N021197||Cetrotide||Cetrorelix Acetate||Serono||S||11-Aug-00||Cetrotide is indicated for the prevention of premature LH surges in women undergoing controlled ovarian stimulation.|
|N021226||Kaletra||Lopinavir; Ritonavir||Abbott Labs||P||15-Sep-00||Keletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections in adults and pediatric patients age six months and older.|
|N021248||Trisenox||Arsenic Trioxide||Cell Therapeutics||P, O||25-Sep-00||Trisenox is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.|
|N020687||Mifeprex||Mifepristone||Population Council||P||28-Sep-00||Mifeprex is indicated for medical termination of intrauterine pregnancy through 49 days’ pregnancy.|
|N020873||Angiomax||Bivalirudin||The Medicines Company||S||15-Dec-00||Angiomax is used as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).|
|N021204||Starlix||Nateglinide||Novartis Pharms||S||22-Dec-00||Provides for the use of Starlix as monotherapy, as an adjunct to diet and exercise to improve gylcemic control in patients with type 2 diabetes. In addition, it provides for the use of Starlix concomitantly with metformin to improve glycemic control.|
P - Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S - Standard Review - Products that do not qualify for priority review.
O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).