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U.S. Department of Health and Human Services

Drugs

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Priority NDA and BLA Approvals in 2003

NDA Number ProprietaryName Established Name Applicant Chemical Type Review Classification Approval Date Indication
N020414 Pyridostigmine Bromide Pyridostigmine Bromide U.S. Army 3 P 05-Feb-03 Pyridostigmine bromide is indicated for prophylaxis against the lethal effects of Soman nerve agent poisoning.
N021481 Fuzeon Enfuvirtide Hoffman-La Roche 1 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 1 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 1 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.
N021588 Gleevec Imatinib Mesylate Novartis Pharms 3 P 18-Apr-03 Gleevec is indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in chronic phase and in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. It is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
N021399 Iressa Gefitinib AstraZeneca 1 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 1 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.
N021567 Reyataz Atazanavir Bristol-Myers Squibb 1 P 20-Jun-03 Reyataz is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
N021546 Rebetol Ribavirin Schering 3 P, O 29-Jul-03 Rebetol is indicated to be used as part of combination therapy with Intron A for the treatment of chronic Hepatitis C among previously untreated pediatric at least three years of age or older.
N021572 Cubicin Daptomycin Cubist 1 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 1 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.
N021320 Plenaxis Abarelix Praecis 1 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.
N021388 Sterile Talc Powder Sterile Talc Powder Bryan 3 P, O 15-Dec-03 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; Fluoxetine Hydrochloride Eli-Lilly 4 P 24-Dec-03 Symbyax is indicated for the use as a combination product in the treatment of depressive episodes associated with bipolar disorder.

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).