 |
CDER
Priority NDA Approvals in
Calendar Year 2003
Updated through December 31, 2003
| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
Indication |
|
N020414 |
Pyridostigmine Bromide |
Pyridostigmine Bromide |
U.S. Army |
3 |
P |
05-Feb-03 |
Pyridostigmine bromide is
indicated for prophylaxis against the lethal effects of Soman
nerve agent poisoning. |
|
N021481 |
Fuzeon |
Enfuvirtide |
Hoffman-La Roche |
1 |
P |
13-Mar-03 |
Fuzeon is indicated for the use
in combination with other antiretroviral agents, for the
treatment of HIV-1 infection in treatment experienced patients
with evidence of HIV-1 replication despite ongoing
antiretroviral therapy. |
|
N021106 |
Somavert |
Pegvisomant |
Pharmacia & Upjohn |
1 |
P, O |
25-Mar-03 |
Somavert is indicated for the
treatment of acromegaly in patients who have an inadequate
response to surgery and/or radiation therapy and/or other
medical therapies, or for whom these therapies are not
appropriate. |
|
N021549 |
Emend |
Aprepitant |
Merck |
1 |
P |
26-Mar-03 |
Emend is indicated to be used in
combination with other antiemetic agents, for the prevention of
acute and delayed nausea and vomiting associated with initial
and repeat courses of highly emetogenic cancer chemotherapy,
including high-dose cisplatin. |
|
N021588 |
Gleevec |
Imatinib Mesylate |
Novartis Pharms |
3 |
P |
18-Apr-03 |
Gleevec is indicated for the
treatment of newly diagnosed adult patients with Philadelphia
chromosome positive chronic myeloid leukemia (CML) in chronic
phase and in blast crisis, accelerated phase, or in chronic
phase after failure of interferon-alpha therapy. It is also
indicated for the treatment of patients with Kit (CD117)
positive unresectable and/or metastatic malignant
gastrointestinal stromal tumors (GIST). |
|
N021399 |
Iressa |
Gefitinib |
AstraZeneca |
1 |
P |
05-May-03 |
Iressa is indicated as
monotherapy for the treatment of patients with locally advanced
or metastatic non-small cell lung cancer after failure of both
platinum-based and docetaxel chemotherapies. |
|
N021602 |
Velcade |
Bortezomib |
Millennium Pharms |
1 |
P, O |
13-May-03 |
Velcade is indicated for the
treatment of multiple myeloma patients who have received at
least two prior therapies and have demonstrated disease
progression on the last therapy. |
|
N021567 |
Reyataz |
Atazanavir |
Bristol-Myers Squibb |
1 |
P |
20-Jun-03 |
Reyataz is indicated in
combination with other antiretroviral agents for the treatment
of HIV-1 infection in adults. |
|
N021546 |
Rebetol |
Ribavirin |
Schering |
3 |
P, O |
29-Jul-03 |
Rebetol is indicated to be used
as part of combination therapy with Intron A for the treatment
of chronic Hepatitis C among previously untreated pediatric at
least three years of age or older. |
|
N021572 |
Cubicin |
Daptomycin |
Cubist |
1 |
P |
12-Sep-03 |
Cubicin is indicated for the
treatment of complicated skin and skin structure infections
caused by susceptible strains of the following Gram-positive
microorganisms: Staphylococcus aureus (including methicillin-resistant
strains), Streptococcus pyogenes, Streptococcus agalactiae,
Streptococcus dysgalactiae subsp. equisililis and Enterococcus
faecalis (vancomycin-susceptible strains only). |
|
N021626 |
Radiogardase |
Prussian Blue |
Heyl Chemisch-pharmazeutische
Fabrik GmbH |
1 |
P, O |
02-Oct-03 |
Radiogardase is indicated for the
treatment of patients with known or suspected internal
contamination with radioactive cesium and/or radioactive or
non-radioactive thallium to increase their rates of elimination. |
|
N021320 |
Plenaxis |
Abarelix |
Praecis |
1 |
P |
25-Nov-03 |
Plenaxis is indicated for the
palliative treatment of men with advanced symptomatic prostate
cancer, in whom LHRH agonist therapy is not appropriate and who
refuse surgical castration, and have one or more of the
following: (1) risk of neurological compromise due to
metastases, (2) ureteral or bladder outlet obstruction due to
local encroachment or metastatic disease, or (3) severe bone
pain from skeletal metastases persisting on narcotic analgesia. |
|
N021388 |
Sterile Talc Powder |
Sterile Talc Powder |
Bryan |
3 |
P, O |
15-Dec-03 |
Sterile Talc Powder is indicated
for administering intrapleurally via chest-tube as a sclerosing
agent to decrease the recurrence of malignant pleural effusions
in symptomatic patients. |
|
N021520 |
Symbyax |
Olanzapine; Fluoxetine
Hydrochloride |
Eli-Lilly |
4 |
P |
24-Dec-03 |
Symbyax is indicated for the use
as a combination product in the treatment of depressive episodes
associated with bipolar disorder. |
Chemical Type:
1 - New molecular entity
2 - New ester, new salt, or other noncovalent
derivative
3 - New formulation
4 - New combination
5 - New manufacturer
7 - Drug already marketed, but without an
approved NDA
Review Classification:
P - Priority Review - Significant
improvement compared to marketed products, in the treatment,
diagnosis, or prevention of a disease.
O - Orphan Designation - Pursuant to
Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).
To access
approval letters, labels, and review packages, go to
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Date created: March 7, 2005; updated
January 19, 2006
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