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 CDER New Molecular Entity (NME) Drug and New Biologic Approvals in Calendar Year 2004
Updated through December 31, 2004

NME New Drug Application (NDA) Approvals:

NDA Number Proprietary Name Established Name Applicant Review Classification Approval Date Indication
N021395 Spiriva Handihaler Tiotropium Bromide Boehringer Ingelheim S 30-Jan-04

Spiriva HandiHaler is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

N021462 Alimta Pemetrexed Disodium Eli Lilly 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 P, O 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.
N021144 Ketek Telithromycin Aventis Pharms S 01-Apr-04 Ketek is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below, for patients 18 years old and above. (1) Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis. (2) Acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis or Staphylococcus aureus. (3) Community-acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP] strains), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae.
N021256 ChiRhoStim Human Secretin Chirhoclin P 09-Apr-04 ChiRhoStim 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).
N021629 Apidra Insulin Glulisine Aventis Pharms S 16-Apr-04 Apidra is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia.
N021264 Apokyn Apomorphine Hydrochloride Bertek P, O 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 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.
N021618 Tindamax Tinidazole Presutti Labs S 17-May-04 Tindamax is indicated for the treatment of trichomoniasis.
N050794 Vidaza Azacitidine Pharmion 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.
N021361 Xifaxan Rifaximin Salix Pharma S 25-May-04 Xifaxan is indicated for the treatment of patients (> 12 years of age) with travelers' diarrhea caused by noninvasive strains of Escherichia coli. Xifaxan should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli.
N021595 Sanctura Trospium Chloride Indevus S 28-May-04 Sanctura is indicated for the treatment of overactive bladder associated with symptoms of urge urinary incontinence, urgency, and urinary frequency.
N021667 NutreStore L-Glutamine Nutritional Restart S, O 10-Jun-04 NutreStore is indicated for the treatment of short bowel syndrome in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth that is approved for this indication.
N021431 Campral Acamprosate Calcium Lipha 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.
N021427 Cymbalta Duloxetine Hydrochloride Eli Lilly S 03-Aug-04 Cymbalta is indicated for the treatment of major depressive disorder (MDD).
N021749 Pentetate Calcium Trisodium Pentetate Calcium Trisodium Pharma Hameln GmbH P, O 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  P, O 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.
N021468 Fosrenol Lanthanum Carbonate Hydrate Shire Pharm S 26-Oct-04 Fosrenol is indicated to reduce serum phosphate in patients with end stage renal disease.
N021665 Amphadase Hyaluronidase Amphastar Pharm P 26-Oct-04 Amphadase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as as adjunct in subcutaneous urography for improving resorption of radiopaque agents.
N021654 Omacor Omega-3-acid Ethyl Esters Ross Prods S 10-Nov-04 Omacor is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with TG levels > 500 mg/dL.
N021743 Tarceva Erlotinib Hydrochloride OSI Pharms 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.
N021518 VESIcare Solifenacin Succinate Yamanouchi S 19-Nov-04 VESIcare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
N021357 Multihance Gadobenate Dimeglumine Bracco S 23-Nov-04 Multihance is indicated for intravenous use in magnetic resonance imaging (MRI) of the CNS in adults to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues.
N021476 Lunesta Eszopicline Sepracor S 15-Dec-04 Lunesta is indicated for the treatment of insomnia.
N021670 Vision Blue Trypan Blue Dorc International BV P 16-Dec-04 Visionblue is indicated as an aid in ophthalmic surgery by staining the anterior capsule of the lens.
N021756 Macugen Pegaptanib Sodium Eyetech Pharms P 17-Dec-04 Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.
N021513 Enablex Darifenacin Hydrobromide Novartis S 22-Dec-04 Enablex is indicated for the treatment of overactive bladder.
N021060 Prialt Ziconotide Elan Pharms 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 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 P, O 29-Dec-04 Ventavis is indicated for the treatment of pulmonary arterial hypertension.
N021446 Lyrica Pregabalin Pfizer P 30-Dec-04 Lyrica is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy.

New 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).
BL103928 NeutroSpec Technetium 99m Tc Fanolesomab Palatin Technologies S 02-Jul-04 NeutroSpec is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older.
BL125104 Tysabri Natalizumab Biogen Idec Inc. 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, Inc. 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.

Review Classification:  
P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S -   Standard Review - Products that do not qualify for priority review.
O -  Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

To access approval letters, labels, and review packages, go to Drugs at FDA Logo links back to Initial Search Page

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Date created: March 5, 2004; updated January 19, 2006

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