NDA
Number
| Proprietary Name |
Established Name |
Applicant |
Review Classification |
Approval Date |
Indication |
| N021938 |
Sutent |
sunitinib
malate |
Pfizer |
P |
26-Jan-06 |
Provides for the treatment of
gastrointestinal stromal tumor after disease progression on
or intolerance to imatinib mesylate. |
| N021526 |
Ranexa |
ranolazine |
CV Therapeutics |
S |
27-Jan-06 |
Provides for the
treatment of chronic angina. Because Ranexa prolongs the QT
interval, it should be reserved for patients who have not
achieved an adequate response with other antianginal
drugs. |
| N021908 |
Amitiza |
lubiprostone |
Sucampo |
S |
31-Jan-06 |
Provides for the
treatment of chronic idiopathic constipation in the adult
population. |
| N021632 |
Eraxis |
anidulafungin |
Vicuron |
S |
17-Feb-06 |
Provides for the treatment of patients with esophageal
candidiasis. |
| N021790 |
Dacogen |
decitabine |
MGI Pharma |
S, O |
02-May-06 |
Provides for the treatment of
myelodysplastic syndrome (MDS). |
| N021928 |
Chantix |
varenicline |
Pfizer |
P |
10-May-06 |
Provides for use as an aid to smoking
cessation. |
| N021641 |
Azilect |
rasagiline mesylate |
Teva |
S |
16-May-06 |
Provides for the treatment of the signs
and symptoms of idiopathic Parkinson's disease as initial
monotherapy and as adjunct therapy to levodopa. |
N021976 |
Prezista |
darunavir |
Tibotec |
P |
23-Jun-06 |
When coadministered with 100 mg
of ritonavir, provides for the treatment of human
immunodeficiency virus (HIV) infection in antiretroviral
treatment-experienced adult patients, such as those with
HIV-1 strains resistant to more than one protease
inhibitor. |
| N021986 |
Sprycel |
dasatinib |
Bristol-Myers Squibb |
P, O |
28-Jun-06 |
Provides for the treatment of adults with
chronic myeloid leukemia with resistance or intolerance to
prior therapy including imatinib. |
| N021502 |
Anthelios
SX |
avobenzone; ecamsule;
octocrylene |
L'Oreal |
S |
21-Jul-06 |
Provides
for the prevention of sunburn and to help provide protection
from UVA and UVB rays. |
| N022003 |
Noxafil |
posaconazole |
Schering |
P |
15-Sep-06 |
Provides for the treatment of
prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and
older, who are at high risk of developing these infections
due to being severely immunocompromised, such as
hematopoietic stem cell transplant (HSCT) recipients with
Graft versus Host Disease (GVHD) or those with hematologic
malignancies with prolonged neutropenia from
chemotherapy. |
| N050786 |
Pylera |
biskalcitrate;
metronidazole; tetracycline hydrochloride |
Axcan
Scandipharm |
S |
28-Sep-06 |
Provides
for the treatment of patients with Helicobacter pylori
infection and duodenal ulcer disease (active or history
of within the past 5 years) to eradicate H.
pylori. |
| N021991 |
Zolinza |
vorinostat |
Merck |
P,O |
06-Oct-06 |
Provides for the treatment of cutaneous manifestations in
patients with cutaneous T-cell lymphoma (CTCL) who have
progressive, persistent or recurrent disease on or following
two systemic therapies. |
| N021995 |
Januvia |
sitagliptin
phosphate |
Merck |
S |
16-Oct-06 |
Provides
for the use as an adjunct to diet and exercise to improve
gylcemic control in patients with type 2 diabetes mellitus
as monotherapy and in combination with metformin or a PPARγ
agonist (e.g., thiazolidinediones) when diet and excercise
plus the single agent do not provide adequate glycemic
control. |
| N022004 |
Omnaris |
ciclesonide |
Altana |
S |
20-Oct-06 |
Provides
for the treatment of seasonal and allergic rhinitis in
patients 12 years of age and older. |
| N022011 |
Tyzeka |
telbivudine |
Idenix |
S |
25-Oct-06 |
Provides
for the treatment of chronic hepatitis B (CHB) in patients
with evidence of viral replication and active liver
inflammation. |
| N021902 |
Veregen |
kunecatechins |
MediGene |
S |
31-Oct-06 |
Provides
for the topical treatment of external genital and perianal
warts (Condylomata acuminata) in immunocompetent
patients 18 years and older. |
| N021999 |
Invega |
paliperidone |
Janssen, L.P. |
S |
19-Dec-06 |
Provides
for the treatment of schizophrenia. |
