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 CDER Priority New Drug and Biologic License Application Approvals in Fiscal Year 2004
as of September 30, 2004

Priority NDA Approvals:

NDA Number Proprietary Name (established name) Applicant Approval Date Chemical Type Review Classification Indication(s)
N021626 Radiogardase                                        (prussian blue) Heyl Chemisch-pharmazeutische Fabrik GmbH  02-Oct-03 1 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.
N021320 Plenaxis                                                 (abarelix) Praecis  25-Nov-03 1 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.
N021388 Sterile Talc Powder                                (sterile talc powder) Bryan 15-Dec-03 3 P, O 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 and fluoxetine hydrochloride) Eli-Lilly 24-Dec-03 4 P Symbyax is indicated for the use as a combination product in the treatment of depressive episodes associated with bipolar disorder.
N021539 Acetadote                             (acetylcysteine) Cumberland Pharms 23-Jan-04 3 P, O

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 04-Feb-04 1 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 1 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.     
N021256 Human Secretin                           (human secretin) Chirhoclin 09-Apr-04 1 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).
N021264 Apokyn                                (apomorphine hydrochloride) Bertek 20-Apr-04 1 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 1 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.
N050794 Vidaza                                      (azacitidine) Pharmion 19-May-04 1 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.
N021497 Alinia                                  (nitazoxanide) Romark 21-Jul-04 3 P Alinia is indicated for the treatment of diarrhea caused by Giardia Lamblia in patients 12 years and older.
N021431 Campral                                      (acamprosate calcium) Lipha 29-Jul-04 1 P 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 02-Aug-04 4 P 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 11-Aug-04 1 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 1 P 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 01-Sep-04 3 P 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.

Priority BLA Approvals:

BLA Number Proprietary Name (proper name) Applicant Approval Date Review Classification Indication(s)

BL125084

 Erbitux                                          (cetuximab) ImClone Systems 12-Feb-04 P

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 26-Feb-04 P

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).

NDA Chemical Type:
1 -   New molecular entity
3 -   New formulation
4 -   New combination
5 -   New manufacturer

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).

 

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Date created: October 15, 2004; updated November 09, 2004

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