CDER Priority Drug and Biologic Approvals in Calendar Year 2004

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FDA/Center for Drug Evaluation and Research

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

Date created: March 7, 2005; updated January 19, 2006