| NDA
Number |
Proprietary
Name (established
name) |
Applicant |
Approval
Date |
Review
Classification |
Indication(s) |
|
N021626 |
Radiogardase (prussian
blue) |
Heyl Chemisch-pharmazeutische Fabrik
GmbH |
02-Oct-03 |
P, O |
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 |
16-Oct-03 |
S |
Namenda is indicated for the treatment of moderate to severe
dementia of the Alzheimer's type. |
|
N021565 |
ELESTAT
(epinastine hydrochloride) |
Allergan |
16-Oct-03 |
S |
ELESTAT is indicated for the prevention of itching
associated with allergic conjunctivitis. |
|
N021368 |
Cialis
(tadalafil) |
Lilly |
21-Nov-03 |
S |
Cialis
is indicated for the treatment of erectile dysfunction. |
|
N021320 |
Plenaxis (abarelix) |
Praecis |
25-Nov-03 |
P |
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 |
10-Dec-03 |
S |
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. |
|
N021395 |
Spiriva
HandiHaler (tiotropium bromide) |
Boehringer
Ingelheim |
30-Jan-04 |
S |
Spiriva HandiHaler is indicated
for the long-term, once-daily, maintenance treatment of
bronchospasm associated with chronic obstructive pulmonary
disease (COPD), including chronic bronchitis and emphysema. |
|
N021462 |
Alimta
(pemetrexed disodium) |
Eli
Lilly |
04-Feb-04 |
P, O |
Alimta is indicated in the
treatment of patients with malignant pleural mesothelioma whose
disease is either unresectable or who are otherwise not
candidates for curative surgery. |
|
N021688 |
Sensipar
(cinacalcet hydrochloride) |
Amgen |
08-Mar-04 |
P |
Sensipar is indicated for the
treatment of secondary hyperparathyroidism in patients with
chronic kidney disease on dialysis, and the treatment of
hypercalcemia in patients with parathyroid carcinoma. |
|
N021144 |
Ketek
(telithromycin) |
Aventis |
01-Apr-04 |
S |
Ketek is indicated for the
treatment of infections caused by susceptible strains of the
designated microorganisms in the conditions listed below, for
patients 18 years old and above. (1) Acute bacterial
exacerbation of chronic bronchitis due to Streptococcus
pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
(2) Acute bacterial sinusitis due to Streptococcus pneumoniae,
Haemophilus influenzae, Moraxella catarrhalis or Staphylococcus
aureus. (3) Community-acquired pneumonia (of mild to moderate
severity) due to Streptococcus pneumoniae (including multi-drug
resistant Streptococcus pneumoniae [MDRSP] strains), Haemophilus
influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or
Mycoplasma pneumoniae. |
|
N021256 |
Human
Secretin
(human secretin) |
Chirhoclin |
09-Apr-04 |
P, O |
Human Secretin is indicated for
(1) Stimulation of pancreatic secretions, including bicarbonate,
to aid in the diagnosis of pancreatic exocrine dysfunction, (2)
Stimulation of gastrin secretion to aid in the diagnosis of
gastrinoma, and (3) Stimulation of pancreatic secretions to
facilitate the identification of the ampulla of Vater and
accessory papilla during endoscopic retrograde
cholangiopancreatography (ERCP). |
|
N021629 |
Apidra
(insulin glulisine) |
Aventis |
16-Apr-04 |
S |
Apidra is indicated for the
treatment of adult patients with diabetes mellitus for the
control of hyperglycemia. |
|
N021264 |
Apokyn
(apomorphine hydrochloride) |
Bertek |
20-Apr-04 |
P |
Apokyn is indicated for the
acute, intermittent treatment of hypomobility, "off" episodes
("end-ofdose wearing off" and unpredictable "on/off" episodes)
associated with advanced Parkinson's disease. |
|
N021640 |
Vitrase
(ovine hyaluronidase) |
Ista
Pharms |
05-May-04 |
P |
Vitrase is indicated as an
adjuvant to increase the absorption and dispersion of other
injected drugs; for hypodermoclysis; and as an adjunct in
subcutaneous urography for improving resorption of radiopaque
agents. |
|
N021618 |
Tindamax
(tinidazole) |
Presutti |
17-May-04 |
S, O |
Tindamax is indicated for the
treatment of trichomoniasis. |
|
N050794 |
Vidaza
(azacitidine) |
Pharmion |
19-May-04 |
P, O |
Vidaza is indicated for the
treatment of patients with the following myelodysplastic
syndrome subtypes: refractory anemia or refractory anemia with
ringed sideroblasts (if accompanied by neutropenia or
thrombocytopenia and requiring transfusions), refractory anemia
with excess blasts, refractory anemia with excess blasts in
transformation, and chronic myelomonocytic leukemia. |
|
N021361 |
Xifaxan
(rifaximin) |
Salix |
25-May-04 |
S |
Xifaxan is indicated for the
treatment of patients (> 12 years of age) with travelers'
diarrhea caused by noninvasive strains of Escherichia coli.
Xifaxan should not be used in patients with diarrhea complicated
by fever or blood in the stool or diarrhea due to pathogens
other than Escherichia coli. |
|
N021595 |
Sanctura
(trospium chloride) |
Indevus |
28-May-04 |
S |
Sanctura is indicated for the
treatment of overactive bladder associated with symptoms of urge
urinary incontinence, urgency, and urinary frequency. |
|
N021667 |
NutreStore
(L-glutamine) |
Nutritional Restart |
10-Jun-04 |
S, O |
NutreStore is indicated for the
treatment of short bowel syndrome in patients receiving
specialized nutritional support when used in conjunction with a
recombinant human growth that is approved for this indication. |
|
N021431 |
Campral
(acamprosate calcium) |
Lipha |
29-Jul-04 |
P |
Campral is indicated for the
maintenance of abstinence from alcohol in patients with alcohol
dependence who are abstinent at treatment initiation. |
|
N021427 |
Cymbalta
(duloxetine hydrochloride) |
Eli Lilly
|
03-Aug-04 |
S |
Cymbalta is indicated for the
treatment of major depressive disorder (MDD). |
| N021749 |
Pentetate Calcium
Trisodium (pentetate calcium
trisodium) |
Pharma Hameln
GmbH |
11-Aug-04 |
P |
Pentetate Calcium Trisodium is
indicated for the treatment of internal contamination with
plutonium, americium or curium to increase the rates of
elimination. |
| N021751 |
Pentetate Zinc
Trisodium (pentetate zinc
trisodium) |
Pharma Hameln
GmbH |
11-Aug-04 |
P |
Pentetate Zinc Trisodium is
indicated for the treatment of internal contamination with
plutonium, americium or curium to increase the rates of
elimination. |
Date created: October 15, 2004; updated
November 09, 2004
