CDER NME Approvals in Calendar Year 2002

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FDA/Center for Drug Evaluation and Research

CDER NME Approvals in Calendar Year 2002
Updated through December 31, 2002

NDA Number	Proprietary Name	Established Name	Applicant	Review Classification	Approval Date	Indication
N021232	Orfadin	Nitisinone	Swedish Orphan	P, O	18-Jan-02	Orfadin provides for the use for adjunctive therapy to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1.
N021286	Benicar	Olmesartan Medoxomil	Sankyo	S	25-Apr-02	Benicar is indicated for the treatment of hypertension.
N021344	Faslodex	Fulvestrant	AstraZeneca	S	25-Apr-02	Faslodex is indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
N021272	Remodulin	Treprostinil Sodium	United Therapeutics	P, O	21-May-02	Remodulin is indicated for the treatment of pulmonary arterial hypertension (PAH).
N021266	Vfend	Voriconazole	Pfizer	S	24-May-02	Vfend is indicated for the treatment of invasive aspergillosis and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp., including Fusarium solani, in patients intolerant of, or refractory to, other therapy.
N021191	Imagent	Perflexane Phospholipid Microspheres	Alliance Pharm	S	31-May-02	Imagent is indicated for the use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
N021196	Xyrem	Sodium Oxybate	Orphan Medical	P, O	17-Jul-02	Xyrem is indicated for the treatment of cataplexy associated with narcolepsy.
N021200	Zelnorm	Tegaserod Maleate	Novartis Pharms	P	24-Jul-02	Zelnorm is indicated for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation.
N021492	Eloxatin	Oxaliplatin	Sanofi-Synthelabo	P	09-Aug-02	Eloxatin is indicated in combination with infusional 5-FU/LV for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus 5-FU/LV and irinotecan.
N021449	Hepsera	Adefovir Dipivoxil	Gilead Sciences	P	20-Sep-02	Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) or histologically active disease.
N021437	Inspra	Eplerenone	GD Searle	S	27-Sep-02	Inspra is indicated for the treatment of hypertension, alone or in combination with other agents.
N021445	Zetia	Ezetimibe	MSP Singapore	S	25-Oct-02	Zetia is indicated for (1) Primary hypercholesterolemia - as adjunctive therapy to diet for reduction of elevated total-C, LDL-C and Apo B in patients with primary (heterozygous familial and non-familial) hypercholestrolemia either alone or with an HMG-Co A reductase inhibitor. (2) Homozygous familial hypercholesterolemai - in combination with either atorvastatin or simvastatin, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or, if such treatments are unavailable, in combination with either atorvastatin or simvastatin alone. (3) Homozygous familial sitosterolemia - as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels.
N021436	Abilify	Aripiprazole	Otsuka	S	15-Nov-02	Abilify is indicated for the treatment of schizophrenia.
N021498	Alinia	Nitazoxanide	Romak Labs	P	22-Nov-02	Alinia is indicated for the treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia.
N021411	Strattera	Atomoxetine Hydrochloride	Eli Lilly	S	26-Nov-02	Strattera is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) for children and adolescents ages 6-18 and adults.
N021321	Extraneal	Icodextrin	Baxter Healthcare	S, O	12-Dec-02	Extraneal is indicated for a single daily exchange for the long (8-16-hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of chronic renal failure.
N021016	Relpax	Eletriptan Hydrobromide	Pfizer	S	26-Dec-02	Replax is indicated for the acute treatment of migrane.

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

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