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CDER
Priority Drug and Biologic Approvals in
Calendar Year 2004
Updated
through December 31, 2004
Priority New Drug Application
(NDA) Approvals:
NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
Indication |
N021539 |
Acetadote |
Acetylcysteine |
Cumberland Pharms |
3 |
P, O |
23-Jan-04 |
Acetadote is indicated to be administered intravenously
within 8 to 10 hours after ingestion of a potentially
hepatotoxic quantity of acetaminophen, to prevent or lessen
hepatic injury. |
N021462 |
Alimta |
Pemetrexed
Disodium |
Eli Lilly |
1 |
P, O |
04-Feb-04 |
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 |
1 |
P |
08-Mar-04 |
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. |
N021256 |
Human
Secretin |
Human
Secretin |
Chirhoclin |
1 |
P, O |
09-Apr-04 |
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). |
N021264 |
Apokyn |
Apomorphine
Hydrochloride |
Bertek |
1 |
P |
20-Apr-04 |
Apokyn is indicated for the acute, intermittent
treatment of hypomobility, "off" episodes ("end-of-dose wearing
off" and unpredictable "on/off" episodes) associated with
advanced Parkinson's disease. |
N021640 |
Vitrase |
Ovine
Hyaluronidase |
Ista Pharms |
1 |
P |
05-May-04 |
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. |
N050794 |
Vidaza |
Azacitidine |
Pharmion |
1 |
P, O |
19-May-04 |
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. |
N021497 |
Alinia |
Nitazoxanide |
Romark |
3 |
P |
21-Jul-04 |
Alinia is indicated for the treatment of diarrhea
caused by Giardia Lamblia in patients 12 years and
older. |
N021431 |
Campral |
Acamprosate
Calcium |
Lipha |
1 |
P |
29-Jul-04 |
Campral is indicated for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are
abstinent at treatment initiation. |
N021752 |
Truvada |
Emtricitabine;
Tenofovir Disoproxil Fumarate |
Gilead Sciences |
4 |
P |
02-Aug-04 |
Truvada is indicated in combination with other
antiretroviral agents (such as non-nucleoside reverse
transcriptase inhibitors or protease inhibitors) for the
treatment of HIV-1 infection in adults. |
N021749 |
Pentetate Calcium
Trisodium |
Pentetate Calcium
Trisodium |
Pharma Hameln GmbH |
1 |
P |
11-Aug-04 |
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 |
1 |
P |
11-Aug-04 |
Pentetate Zinc Trisodium is indicated for the treatment
of internal contamination with plutonium, americium or curium
to increase the rates of elimination. |
N021563 |
Clarinex |
Desloratadine |
Schering |
3 |
P |
01-Sep-04 |
Clarinex is indicated for the relief of the nasal and
non-nasal symptoms of perennial allergic rhinitis, and the
symptomatic relief of pruritus, reduction in the number of
hives, and size of hives, in patients with chronic idiopathic
urticaria in children 6 months to 2 years of
age. |
N021683 |
Manoplex |
Insoluble
Prussian Blue |
Degussa
Limited |
5 |
P |
14-Oct-04* |
Manoplex 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. |
N021665 |
Amphadase
(hyaluronidase) |
Amphadase
(hyaluronidase) |
Amphastar
Pharms |
1 |
P |
26-Oct-04 |
Amphadase 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. |
N021743 |
Tarceva
(erlotinib) |
Tarceva
(erlotinib) |
OSI Pharms |
1 |
P |
18-Nov-04 |
Tarceva is indicated for the
treatment of locally advanced or metastatic Non Small-Cell Lung
Cancer (NSCLC) after failure of at least one prior chemotherapy
regimen. |
N021786 |
Kelacal |
Pentetate
Calcium Trisodium |
CIS-US |
5 |
P |
01-Dec-04* |
Kelacal is indicated for the
treatment of internal contamination with plutonium, americium,
or curium. |
N021787 |
Kelazin |
Pentetate
Zinc Trisodium |
CIS-US |
5 |
P |
01-Dec-04* |
Kelazin is indicated for the
treatment of internal contamination with plutonium, americium,
or curium. |
N021670 |
Vision Blue |
Trypan
Blue |
DORC |
1 |
P |
16-Dec-04 |
Vision Blue
is indicated as an aid in ophthalmic surgery by staining the
anterior capsule of the lens. |
N021756 |
Macugen |
Pegaptanib
sodium |
Eyetech |
1 |
P |
17-Dec-04 |
Macugen is
indicated for the treatment of neovascular (wet) age-related
macular degeneration. |
N021785 |
Invirase |
Saquinavir
Mesylate |
Hoffman-La
Roche |
3 |
P |
17-Dec-04 |
Invirase
is indicated in combination with other antiretroviral agents for
the treatment of HIV-1 infection in adults. |
N021060 |
Prialt |
Ziconotide |
Elan
Pharms |
1 |
P |
28-Dec-04 |
Prialt is
indicated for the management of severe chronic pain in patients
for whom intrathecal (IT) therapy is warranted and who are
intolerant of or refractory to other treatment, such as systemic
analgesics, adjunctive therapies, or IT morphine. |
N021673 |
Clolar |
Clofarabine |
Genzyme |
1 |
P, O |
28-Dec-04 |
Clolar is
indicated for the treatment of pediatric patients 1 to 21 years
old with relapsed or refractory acute lymphoblastic leukemia
after at least two prior regimens. |
N021779 |
Ventavis |
Iloprost |
CoTherix |
1 |
P, O |
29-Dec-04 |
Ventavis
is indicated for the treatment of pulmonary arterial
hypertension. |
N021446 |
Lyrica |
Pregabalin |
Pfizer |
1 |
P |
30-Dec-04 |
Lyrica is
indicated for the management of neuropathic pain associated with
diabetic peripheral neuropathy. |
Priority Biologic License Application (BLA)
Approvals:
BLA Number |
Proprietary
Name |
Proper Name |
Applicant |
Review Classification |
Approval
Date |
Indication |
BL125084 |
Erbitux |
Cetuximab |
ImClone Systems |
P |
12-Feb-04 |
Erbitux is indicated
for the treatment of EGFR-expressing, metastatic colorectal
carcinoma in patients who are refractory to irinotecan-based
chemotherapy (in combination with irinotecan); Treatment of
EGFR-expressing, metastatic colorectal carcinoma in patients
who are intolerant to irinotecan-based chemotherapy
(administered as a single agent). |
BL125085 |
Avastin |
Bevacizumab |
Genentech |
P |
26-Feb-04 |
Avastin is indicated
for the first-line treatment of patients with metastatic
carcinoma of the colon and rectum (in combination with
intravenous 5-fluorouracil-based
chemotherapy). |
BL125104 |
Tysabri |
Natalizumab |
Biogen Idec |
P |
23-Nov-04 |
Tysabri is indicated in the
treatment of patients with relapsing forms of multiple sclerosis
(MS) to reduce the frequency of clinical exacerbations. |
BL125103 |
Kepivance |
Palifermin |
Amgen |
P |
15-Dec-04 |
Kepivance is indicated to
decrease the incidence and duration of severe oral mucositis in
patients with hematologic malignancies receiving myelotoxic
therapy requiring hematopoietic stem cell support. |
NDA 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).
* NDA 21683, Manoplex was tentatively
approved on October 14, 2004.
* NDA 21786, Kelacal was tentatively approved
on December 1, 2004.
* NDA 21787, Kelazin was tentatively approved
on December 1, 2004.
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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