| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Review
Classification |
Approval
Date |
Indication |
|
N021481 |
Fuzeon |
Enfuvirtide |
Hoffman-La Roche |
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 |
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 |
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. |
|
N021158 |
Factive |
Gemifloxacin Mesylate |
LG Life Sciences, Ltd |
S |
04-Apr-03 |
Factive is indicated for the
treatment of community-acquired pneumonia and acute bacterial
exacerbation of chronic bronchitis. |
|
N021399 |
Iressa |
Gefitinib |
AstraZeneca |
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 |
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. |
|
N021455 |
Boniva |
Ibandronate Sodium |
Hoffman-La Roche |
S |
16-May-03 |
Boniva is indicated for the
treatment and prevention of postmenopausal osteoporosis. |
|
N021287 |
Uroxatral |
Alfuzosin Hydrochloride |
Sanofi-Synthelabo |
S |
12-Jun-03 |
Uroxatral is indicated for the
treatment of the signs and symptoms of benign prostatic
hyperplasia (BPH). |
|
N021567 |
Reyataz |
Atazanavir |
Bristol-Myers Squibb |
P |
20-Jun-03 |
Reyataz is indicated in
combination with other antiretroviral agents for the treatment
of HIV-1 infection in adults. |
|
N021500 |
Emtriva |
Emtricitabine |
Gilead Sciences |
S |
02-Jul-03 |
Emtriva is indicated for the
treatment of HIV infection in adults. |
|
N021372 |
Aloxi |
Palonosetron Hydrochloride |
Helsinn Healthcare S.A. |
S |
25-Jul-03 |
Aloxi is indicated for 1) the
prevention of acute nausea and vomiting associated with initial
and repeat courses of moderately and highly emetogenic cancer
chemotherapy, and 2) the prevention of delayed nausea and
vomiting associated with initial and repeat courses of
moderately emetogenic cancer chemotherapy. |
|
N021348 |
Zavesca |
Miglustat |
Actelion |
S, O |
31-Jul-03 |
Zavesca is indicated for the
treatment of mild to moderate Type I Gaucher disease in adults
for whom enzyme replacement therapy is not a therapeutic option
(e.g., due to constraints such as allergy, hypersensitivity, or
poor venous access). |
|
N021366 |
Crestor |
Rosuvastatin Calcium |
IRP AstraZenca |
S |
12-Aug-03 |
Crestor is incated as (1) an
adjunct to diet to reduce elevated total-C in patients with
primary hypercholesterolemia (heterozygous familial and
nonfamilial) and mixed dyslipidemia (Frederickson Type IIa and
IIb). (2) as an adjunct to diet for the treatment of patients
with elevated serum TG levels (Frederickson Type IV). (3) to
reduce LDL-C, total-C, and ApoB in patients with homozygous
familial hypercholesterolemia as an adjunct to other
lipid-lowering treatments (e.g., LDL apheresis) or if such
treatments are unavailable) |
|
N021400 |
Levitra |
Vardenafil Hydrochloride |
Bayer |
S |
19-Aug-03 |
Levitra is indicated for the
treatment of erectile dysfunction in men. |
|
N021572 |
Cubicin |
Daptomycin |
Cubist |
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 |
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. |
|
N021487 |
Namenda |
Memantine Hydrochloride |
Forest Labs |
S |
16-Oct-03 |
Namenda is indicated for the
treatment of moderate to severe dementia of the Alzheimer's
type. |
|
N021565 |
ELESTAT |
Epinastine Hydrochloride |
Allergan |
S |
16-Oct-03 |
Elestat is indicated for the
prevention of itching associated with allergic conjunctivitis. |
|
N021368 |
Cialis |
Tadalafil |
Lilly |
S |
21-Nov-03 |
Cialis is indicated for the
treatment of erectile dysfunction. |
|
N021320 |
Plenaxis |
Abarelix |
Praecis |
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. |
|
N021385 |
Ertaczo |
Sertaconazole Nitrate |
Mylan |
S |
10-Dec-03 |
Ertaczo is indicated for the
topical treatment of interdigital tenea pedis in immunocompetent
patients 12 years of age and older, caused by Trichophyton
rubrum, Trichophyton mentagrophytes, and Epidermophyton
floccosum. |
