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NME Drug and New Biologic Approvals in 2000

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.

Review Classification:  
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).

Page Last Updated: 10/04/2016
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