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 
