| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Review
Classification |
Approval
Date |
Indication |
|
N020989 |
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. |
|
N021014 |
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. |
|
N020987 |
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). |
|
N021107 |
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. |
|
N021084 |
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. |
|
N020971
|
Septocaine |
Articaine
Hydrochloride, Epinephrine |
Deproco |
S |
03-Apr-00 |
Septocaine
is indicated for infiltration or nerve block anesthesia for
dentistry. |
|
N021119
|
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. |
