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U.S. Department of Health and Human Services

Drugs

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NME Drug and New Biologic Approvals in 2003

Updated through December 31, 2003

NDA Number Proprietary Name Established Name Applicant Review Classification Approval Date Indication
N021481 Fuzeon Enfuvirtide Hoffman-La Roche P 13-Mar-03

Fuzeon is indicated for the use in combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

N021106 Somavert Pegvisomant Pharmacia & Upjohn P, O 25-Mar-03

Somavert is indicated for the treatment of acromegaly in patients who have an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate.

N021549 Emend Aprepitant Merck P 26-Mar-03 Emend is indicated to be used in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin.
N021158 Factive Gemifloxacin Mesylate LG Life Sciences, Ltd S 04-Apr-03 Factive is indicated for the treatment of community-acquired pneumonia and acute bacterial exacerbation of chronic bronchitis.
N021399 Iressa Gefitinib AstraZeneca P 05-May-03 Iressa is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
N021602 Velcade Bortezomib Millennium Pharms P, O 13-May-03 Velcade is indicated for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy.
N021455 Boniva Ibandronate Sodium Hoffman-La Roche S 16-May-03 Boniva is indicated for the treatment and prevention of postmenopausal osteoporosis.
N021287 Uroxatral Alfuzosin Hydrochloride Sanofi-Synthelabo S 12-Jun-03 Uroxatral is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
N021567 Reyataz Atazanavir Bristol-Myers Squibb P 20-Jun-03 Reyataz is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
N021500 Emtriva Emtricitabine Gilead Sciences S 02-Jul-03 Emtriva is indicated for the treatment of HIV infection in adults.
N021372 Aloxi Palonosetron Hydrochloride Helsinn Healthcare S.A. S 25-Jul-03 Aloxi is indicated for 1) the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, and 2) the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
N021348 Zavesca Miglustat Actelion S, O 31-Jul-03 Zavesca is indicated for the treatment of mild to moderate Type I Gaucher disease in adults for whom enzyme replacement therapy is not a therapeutic option (e.g., due to constraints such as allergy, hypersensitivity, or poor venous access).
N021366 Crestor Rosuvastatin Calcium IRP AstraZenca S 12-Aug-03 Crestor is incated as (1) an adjunct to diet to reduce elevated total-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Type IIa and IIb). (2) as an adjunct to diet for the treatment of patients with elevated serum TG levels (Frederickson Type IV). (3) to reduce LDL-C, total-C, and ApoB in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable)
N021400 Levitra Vardenafil Hydrochloride Bayer S 19-Aug-03 Levitra is indicated for the treatment of erectile dysfunction in men.
N021572 Cubicin Daptomycin Cubist P 12-Sep-03 Cubicin is indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisililis and Enterococcus faecalis (vancomycin-susceptible strains only).
N021626 Radiogardase Prussian Blue Heyl Chemisch-pharmazeutische Fabrik GmbH P, O 02-Oct-03 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.
N021487 Namenda Memantine Hydrochloride Forest Labs S 16-Oct-03 Namenda is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
N021565 ELESTAT Epinastine Hydrochloride Allergan S 16-Oct-03 Elestat is indicated for the prevention of itching associated with allergic conjunctivitis.
N021368 Cialis Tadalafil Lilly S 21-Nov-03 Cialis is indicated for the treatment of erectile dysfunction.
N021320 Plenaxis Abarelix Praecis P 25-Nov-03 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.
N021385 Ertaczo Sertaconazole Nitrate Mylan S 10-Dec-03 Ertaczo is indicated for the topical treatment of interdigital tenea pedis in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

 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).