| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
Indication |
|
N021107 |
Lotronex |
Alosetron
Hydrochloride |
Glaxo
Wellcome |
1 |
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 |
Perfluoropolymethylisopropyl Ether; Polytetrafluoroethylene |
U.S. Army |
1, 4 |
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. |
|
N021114 |
Betaxon |
Levobetaxolol Hydrochloride |
Alcon |
2 |
P |
23-Feb-00 |
Betraxon is indicated
for lowering intraocular pressure in patients with chronic
open-angle glaucoma or ocular hypertension. |
|
N021119 |
Visudyne |
Verteporfin |
QLT Photo |
1 |
P |
12-Apr-00 |
Visudyne provides for
the treatment of age-related macular degeneration in patients
with predominantly classic subfoveal choroidal
neovascularization. |
|
N021130 |
Zyvox |
Linezolid |
Pharmacia & Upjohn |
1 |
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. |
|
N021131 |
Zyvox |
Linezolid |
Pharmacia & Upjohn |
3 |
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. |
|
N021132 |
Zyvox |
Linezolid |
Pharmacia & Upjohn |
3 |
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. |
|
N021174 |
Mylotarg |
Gemtuzumab
Ozogamicin |
Wyeth-Ayerst |
1 |
P, O |
17-May-00 |
Mylotarg
is indicated for the treatment pf 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. |
|
N021056 |
Targretin |
Bexarotene |
Ligand
Pharm |
3 |
P, O |
28-Jun-00 |
Targretin
gel 1% is indicated for the treatment of cutaneous lesions in
patients with CTCL (Stage 1A and 1B) who have refractory or
persistent disease after other therapies or who have not
tolerated other therapies. |
|
N021078 |
Malarone;
Malarone Pediatric |
Atovaquone;
Proguanil Hydrochloride |
Glaxo
Wellcome |
4 |
P |
14-Jul-00 |
Malarone
is indicated for the treatment and prevention of plasmodium
falciparum malaria. |
|
N021214 |
Rescula |
Unoprostone
Isopropyl |
Ciba Vision |
1 |
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. |
|
N020929 |
Pulmicort
Respules |
Budesonide |
AstraZeneca
|
3 |
p |
08-Aug-00 |
Pulmicort
Respules is indicated for the maintenance treatment of asthma
and as prophylactic therapy in children 12 months to 8 years of
age. |
|
N021199 |
Quixin |
Levofloxacin |
Santen |
3 |
P |
18-Aug-00 |
Quixin
is indicated for the treatment of bacterial conjunctivitis. |
|
N021226 |
Kaletra |
Lopinavir;
Ritonavir |
Abbott Labs |
1, 4 |
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. |
|
N021251 |
Kaletra |
Lopinavir;
Ritonavir |
Abbott Labs |
3, 4 |
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 |
1 |
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 |
1 |
P |
28-Sep-00 |
Mifeprex
is indicated for the medical termination of intrauterine
pregnancy through 49 days’ pregnancy. |
|
N021183 |
Videx
EC
|
Didanosine
|
Bristol-Myers Squibb |
3 |
P |
31-Oct-00 |
Videx
EC, in combination with other antiretroviral agents, is
indicated for the treatment of HIV-1 infection in adults whose
management requires once-daily administration of didanosine or
an alternative didanosine formulation. |
|
N021205 |
Trizivir |
Abacavir
Sulfate; Lamivudine; Zidovudine |
Glaxo
Wellcome |
3 |
P |
14-Nov-00 |
Trizivir provides for the
use either alone or in combination with other antiretroviral
agents for the treatment of HIV-1 infection. |
|
N021246 |
Tamiflu |
Oseltamivir
Phosphate |
Hoffmann-La Roche |
3 |
P |
14-Dec-00 |
Tamiflu is indicated for
the treatment of uncomplicated acute illness due to influenza in
patients older than one year of age who have been symptomatic
for no longer than 2 days. |
