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U.S. Department of Health and Human Services

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Priority NDA and BLA Approvals in 2004

Priority New Drug Application (NDA) Approvals:

NDA Number ProprietaryName 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 ProprietaryName 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.