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|
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.|
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).