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